The following data is part of a premarket notification filed by Regulatory Strategies, Inc. with the FDA for Model Me 300 Muscle Tester.
| Device ID | K943535 |
| 510k Number | K943535 |
| Device Name: | MODEL ME 300 MUSCLE TESTER |
| Classification | Device, Biofeedback |
| Applicant | REGULATORY STRATEGIES, INC. 1660 RIVERTON POINT Eagan, MN 55122 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison REGULATORY STRATEGIES, INC. 1660 RIVERTON POINT Eagan, MN 55122 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1997-06-25 |
| Summary: | summary |