| Primary Device ID | 00857599005073 |
| NIH Device Record Key | 114c620d-30f1-42e0-95a9-239f053b0cd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | sam |
| Version Model Number | sam-12 |
| Company DUNS | 080128497 |
| Company Name | ZETROZ SYSTEMS, LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857599005073 [Primary] |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-10 |
| 00857599005202 - sam X1 | 2022-10-07 The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries |
| 00857599005196 - sam 2.0 Long Duration Ultrasound Device for Home Use | 2021-12-08 The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal in |
| 00857599005073 - sam | 2018-07-06wearable therapeutic ultrasound |
| 00857599005073 - sam | 2018-07-06 wearable therapeutic ultrasound |
| 00857599005097 - sam coupling patch | 2018-07-06 coupling patch for use with sam wearable ultrasound device |