The following data is part of a premarket notification filed by Kinetic Resources, Inc. with the FDA for David Back Clinic System.
Device ID | K952163 |
510k Number | K952163 |
Device Name: | DAVID BACK CLINIC SYSTEM |
Classification | Exerciser, Measuring |
Applicant | KINETIC RESOURCES, INC. ATTORNEY AT LAW 616 TEXAS STREET Fort Worth, TX 76102 -4612 |
Contact | W. A Hudson, Ii |
Correspondent | W. A Hudson, Ii KINETIC RESOURCES, INC. ATTORNEY AT LAW 616 TEXAS STREET Fort Worth, TX 76102 -4612 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-08 |
Decision Date | 1996-08-12 |