The following data is part of a premarket notification filed by Emsi with the FDA for Flex-mt +.
Device ID | K140467 |
510k Number | K140467 |
Device Name: | FLEX-MT + |
Classification | Stimulator, Muscle, Powered |
Applicant | EMSI 815 KING STREET STE 206 Alexandria, VA 22314 |
Contact | Cherita James |
Correspondent | Cherita James EMSI 815 KING STREET STE 206 Alexandria, VA 22314 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-24 |
Decision Date | 2014-10-07 |
Summary: | summary |