The following data is part of a premarket notification filed by Innovative Medical Technologies, Inc. with the FDA for Carpal Box.
| Device ID | K936087 |
| 510k Number | K936087 |
| Device Name: | CARPAL BOX |
| Classification | System, X-ray, Stationary |
| Applicant | INNOVATIVE MEDICAL TECHNOLOGIES, INC. 2629 DURANT OAKS DR. Valrico, FL 33594 |
| Contact | Steve W Clapp |
| Correspondent | Steve W Clapp INNOVATIVE MEDICAL TECHNOLOGIES, INC. 2629 DURANT OAKS DR. Valrico, FL 33594 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-21 |
| Decision Date | 1994-10-20 |