The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Transcutaneous Electronic Nerve Stimulator.
| Device ID | K896825 |
| 510k Number | K896825 |
| Device Name: | TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | INFRASONICS CORP. 3944B N.E. 5TH AVE. Oakland Park, FL 33334 |
| Contact | Marvin P Curry |
| Correspondent | Marvin P Curry INFRASONICS CORP. 3944B N.E. 5TH AVE. Oakland Park, FL 33334 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-05 |
| Decision Date | 1990-11-16 |