The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Intelect Model 700.
Device ID | K813594 |
510k Number | K813594 |
Device Name: | INTELECT MODEL 700 |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | CHATTANOOGA GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-27 |
Decision Date | 1982-02-22 |