The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for High Voltage Galvanic Stimulator 550.
Device ID | K813456 |
510k Number | K813456 |
Device Name: | HIGH VOLTAGE GALVANIC STIMULATOR 550 |
Classification | Stimulator, Muscle, Powered |
Applicant | CHATTANOOGA GROUP, 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 | 1981-11-27 |
Decision Date | 1982-01-29 |