The following data is part of a premarket notification filed by Human Performance Technologies, Inc. with the FDA for 2k-qda Motion/gait Analysis System.
| Device ID | K880631 |
| 510k Number | K880631 |
| Device Name: | 2K-QDA MOTION/GAIT ANALYSIS SYSTEM |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | HUMAN PERFORMANCE TECHNOLOGIES, INC. 12 TECHNOLOGY DRIVE, SUITE 6 East Setauket, NY 11733 |
| Contact | Michael E Witover |
| Correspondent | Michael E Witover HUMAN PERFORMANCE TECHNOLOGIES, INC. 12 TECHNOLOGY DRIVE, SUITE 6 East Setauket, NY 11733 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-16 |
| Decision Date | 1988-04-21 |