Flex-Tone
GUDID 00856817005659
AXELGAARD MANUFACTURING CO., LTD.
Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use| Primary Device ID | 00856817005659 |
| NIH Device Record Key | fcf909e3-ca25-4b55-bb1d-46946c0ea3b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flex-Tone |
| Version Model Number | FT660 |
| Company DUNS | 150959401 |
| Company Name | AXELGAARD MANUFACTURING CO., 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856817005659 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132422
FDA Product Code
| GXY | Electrode, Cutaneous |
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 | 2018-07-06 |
| Device Publish Date | 2016-03-31 |
Devices Manufactured by AXELGAARD MANUFACTURING CO., LTD.
| 00851913006241 - PALS CLINICAL | 2023-06-14 2" x 2" square |
| 00851913006258 - PALS CLINICAL | 2023-06-14 2" X 4" rectangle |
| 00851913006272 - Ultrastim Dual | 2022-03-31 Universal Dual Electrode |
| 00851913006319 - UltraStim X Blue | 2021-04-21 |
| 00851913006326 - UltraStim X Blue | 2021-04-21 |
| 00851913006197 - EconoStim | 2020-01-15 1.2" x 2" (3cm x 5cm) Rectangle |
| 00851913006203 - EconoStim | 2020-01-15 2" (5 cm) Round |
| 00851913006210 - EconoStim | 2020-01-15 2" x 2" (5cm x 5cm) Square |
Trademark Results [Flex-Tone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEX-TONE 77541695 3955243 Live/Registered |
E.S. Originals, Inc. 2008-08-07 |
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