The following data is part of a premarket notification filed by Emsi, Inc. with the FDA for Flex-mi.
| Device ID | K221958 |
| 510k Number | K221958 |
| Device Name: | Flex-MI |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EMSI, Inc. 3504 Cragmont Sr., Suite 100 Tampa, FL 33619 |
| Contact | Chad Sagnip |
| Correspondent | Cherita James M Squared Associates,Inc. 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859718007272 | K221958 | 000 |