Flex-Mt +
by Emsi
510(k) K140467
Flex-Mt + is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Emsi, cleared under FDA 510(k) K140467 on 7 Oct 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140467 | Date7 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K140467
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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- COSMODYN-S INTERFERENTIAL MUSCLE STIM by Leo Unlimited, Inc.
- THE SIGNATURE SERIES, IC II by Progressive Electrical Therapeutics