The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Tti Rehabilatation Gym Sys.
Device ID | K841112 |
510k Number | K841112 |
Device Name: | TTI REHABILATATION GYM SYS |
Classification | Stimulator, Muscle, Powered |
Applicant | THERAPEUTIC TECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-15 |
Decision Date | 1984-04-04 |