The following data is part of a premarket notification filed by Orthopedic Technology Research, Inc. with the FDA for Index Shoe.
| Device ID | K960307 |
| 510k Number | K960307 |
| Device Name: | INDEX SHOE |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | ORTHOPEDIC TECHNOLOGY RESEARCH, INC. 819 WEST STRYKER AVE. SUITE 10 Sacramento, CA 95834 |
| Contact | Brian T Cleary |
| Correspondent | Brian T Cleary ORTHOPEDIC TECHNOLOGY RESEARCH, INC. 819 WEST STRYKER AVE. SUITE 10 Sacramento, CA 95834 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-22 |
| Decision Date | 1996-06-27 |
| Summary: | summary |