The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Neuromuscular Electrical Stimulator.
| Device ID | K940349 |
| 510k Number | K940349 |
| Device Name: | NEUROMUSCULAR ELECTRICAL STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
| Contact | Ray Fischer |
| Correspondent | Ray Fischer PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-04-01 |