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 |