The following data is part of a premarket notification filed by Electro-med Health Industries, Inc. with the FDA for Versa Stim 380, Muscle Stimulator.
| Device ID | K852077 |
| 510k Number | K852077 |
| Device Name: | VERSA STIM 380, MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ELECTRO-MED HEALTH INDUSTRIES, INC. 6240 N.E. FOURTH COURT Miami, FL 33138 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz ELECTRO-MED HEALTH INDUSTRIES, INC. 6240 N.E. FOURTH COURT Miami, FL 33138 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-08-21 |