MYODAC2 Biofeedback Device
510(k) K894840
MYODAC2 Biofeedback Device is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K894840 on 13 Oct 1989, 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 | NumberK894840 | Date13 Oct 1989 | StatusActive |
Official records
- FDA 510(k) database K894840
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- Withdrawn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
Similar devices
Other devices filed under FDA product code HCC (Device, Biofeedback).
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- MA-400 EMB FEEDBACK DEVICE by Spectral Data Systems
- ORALSENSOR by Cycura Corp.
- MYO-ACTUATOR by Verimed Holdings, Inc.
- BIOFEEDBACK SYSTEM/3 by Davicon, Inc.
- TEMP. & GSR BIOFEEDBACK DEVICE by Electronics Research & Production
- MINIATURE TEMPERATURE TRAINER MODEL DT-002 by Bio-Feedback Systems, Inc.
- SYNERGY PLUS by THE PROMETHEUS GROUP