The following data is part of a premarket notification filed by Motion Analysis Corp. with the FDA for Spinetrak.
Device ID | K890074 |
510k Number | K890074 |
Device Name: | SPINETRAK |
Classification | Interactive Rehabilitation Exercise Devices |
Applicant | MOTION ANALYSIS CORP. 3650 NORTH LAUGHLIN RD. Santa Rosa, CA 95403 |
Contact | Hand, Phd |
Correspondent | Hand, Phd MOTION ANALYSIS CORP. 3650 NORTH LAUGHLIN RD. Santa Rosa, CA 95403 |
Product Code | LXJ |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-09 |
Decision Date | 1989-02-03 |