510(k) K880631
K880631 is an FDA 510(k) premarket notification submitted by Human Performance Technologies, Inc. for the device "2K-QDA MOTION/GAIT ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Human Performance Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1988
- Date Received
- February 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interactive Rehabilitation Exercise Devices
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type