MYOTRAC2
510(k) K915858
MYOTRAC2 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K915858 on 9 Sep 1992, 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 | NumberK915858 | Date9 Sep 1992 | StatusActive |
Official records
- FDA 510(k) database K915858
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCC
- FDA applicant
- Thought Technology , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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- PROFESSIONAL MARK I BIOFEEDBACK SYS by Srs Co.
- MyoPro 2+ Motion G Left - 28462 rev1 by Myomo, Inc.
- TA-400 TEMP. FEEDBACK DEVICE by Spectral Data Systems
- LIFE-TECH #1753 BIOFEEDBACK TRAINER by Life-Tech Instruments, Inc.