EMG System
510(k) K111687
EMG System is a medical device (FDA Class II; FDA product code HCC, Device, Biofeedback) made by Myotronics-Noromed, Inc., cleared under FDA 510(k) K111687 on 29 Sep 2011, 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 | NumberK111687 | Date29 Sep 2011 | StatusActive |
Official records
- FDA 510(k) database K111687
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code HCC (Device, Biofeedback).
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- ALPHA DETECTOR by M.O.E Electronics Research & Prod.
- MyoPro Motion E Left - 25744 by Myomo, Inc.