The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Therapeutic Ultrasound And Stimulator.
Device ID | K935324 |
510k Number | K935324 |
Device Name: | THERAPEUTIC ULTRASOUND AND STIMULATOR |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. Hixson, TN 37343 |
Contact | Grahame R Watts |
Correspondent | Grahame R Watts CHATTANOOGA GROUP, INC. 4717 ADAMS RD. Hixson, TN 37343 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-05 |
Decision Date | 1994-05-26 |