The following data is part of a premarket notification filed by Body Therapeutics, Inc. with the FDA for Vari-support Low Back Posture Pillow.
Device ID | K821838 |
510k Number | K821838 |
Device Name: | VARI-SUPPORT LOW BACK POSTURE PILLOW |
Classification | Support, Patient Position |
Applicant | BODY THERAPEUTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCX |
CFR Regulation Number | 868.6820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-22 |
Decision Date | 1982-07-20 |