The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Brace Neutralizer.
| Device ID | K932592 |
| 510k Number | K932592 |
| Device Name: | BRACE NEUTRALIZER |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Dan W Miller |
| Correspondent | Dan W Miller SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1994-03-18 |