The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Stimulator, Nerve, Transcutaneous, (pain Relief) 84-gzj.
| Device ID | K940600 |
| 510k Number | K940600 |
| Device Name: | STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-10 |
| Decision Date | 1995-09-29 |