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 |