The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Myo-actuator.
| Device ID | K852963 |
| 510k Number | K852963 |
| Device Name: | MYO-ACTUATOR |
| Classification | Device, Biofeedback |
| Applicant | VERIMED HOLDINGS, INC. 2888 NE 25TH. COURT Fort Lauderdale, FL 33305 |
| Contact | William W Mee |
| Correspondent | William W Mee VERIMED HOLDINGS, INC. 2888 NE 25TH. COURT Fort Lauderdale, FL 33305 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-12 |
| Decision Date | 1986-01-21 |