The following data is part of a premarket notification filed by Emsi with the FDA for Flex-tens.
| Device ID | K090717 |
| 510k Number | K090717 |
| Device Name: | FLEX-TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMSI 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James EMSI 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-18 |
| Decision Date | 2009-05-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLEX-TENS 85337347 4234807 Live/Registered |
Electrostim Medical Services, Inc. 2011-06-03 |