Sofwave FG00001
GUDID 07290018152003
FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
SOFWAVE MEDICAL LTD
Ultrasonic skin contouring system| Primary Device ID | 07290018152003 |
| NIH Device Record Key | 750d9437-527d-4f1f-8a7a-90ee00f9a54c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sofwave |
| Version Model Number | FG00001 |
| Catalog Number | FG00001 |
| Company DUNS | 531962539 |
| Company Name | SOFWAVE MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290018152003 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191421
FDA Product Code
| NXG | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2019-11-10 |
Devices Manufactured by SOFWAVE MEDICAL LTD
| 07290018152171 - Pure Impact Touch control Module | 2025-09-16 Touch control Module (all in one PC and screen) for Powered Muscle Stimulator (EMS) |
| 07290018152089 - Sofwave Applicator | 2025-02-24 The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional c |
| 07290018152133 - SofWave Pure Impact Stimulation Modules Charging Station | 2024-01-15 Charging station for Powered Muscle Stimulator (EMS) |
| 07290018152140 - SofWave Pure Impact Wireless Stimulation Module | 2024-01-15 Powered Muscle Stimulator (EMS) |
| 17290018152154 - SofWave Pure Impact Electode Pads | 2024-01-15 Electrode Pads for Powered Muscle Stimulator (EMS) |
| 07290018152058 - Sofwave Applicator | 2023-05-02 The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional c |
| 07290018152065 - Sofwave Applicator | 2023-05-02 This applicator is the refurbish version of the small (precise) applicator, designed to allow the user treatment flexibility and |
| 07290018152027 - Sofwave Applicator | 2021-06-04 |
Trademark Results [Sofwave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFWAVE 88982651 not registered Live/Pending |
Sofwave Medical Ltd. 2018-11-13 |
 SOFWAVE 88979408 not registered Live/Pending |
Sofwave Medical Ltd. 2018-11-13 |
 SOFWAVE 88191689 not registered Live/Pending |
Sofwave Medical Ltd. 2018-11-13 |
 SOFWAVE 72079235 0712656 Dead/Cancelled |
GILLETTE COMPANY, THE 1959-08-10 |
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