The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Therapeutic Stim 200 (ts-200)/200p (ts-200p).
Device ID | K932399 |
510k Number | K932399 |
Device Name: | THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) |
Classification | Stimulator, Muscle, Powered |
Applicant | MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls, WI 53051 |
Contact | Hassan Hamedi |
Correspondent | Hassan Hamedi MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls, WI 53051 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-18 |
Decision Date | 1993-08-11 |