The following data is part of a premarket notification filed by Rehabilicare, Inc. with the FDA for Ortho Dx Neuromuscular Stimulator.
| Device ID | K971542 |
| 510k Number | K971542 |
| Device Name: | ORTHO DX NEUROMUSCULAR STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Contact | Gary L Moore |
| Correspondent | Gary L Moore REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-08-14 |
| Summary: | summary |