Vari-Support Low Back Posture Pillow

FDA 510(k) K821838 · Body Therapeutics, Inc.

Substantially Equivalent

510(k) numberK821838

Submission

Device name
Vari-Support Low Back Posture Pillow
Applicant
Body Therapeutics, Inc.
Mchenry, IL, US
Received
June 22, 1982
Decision date
July 20, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CCX – Support, Patient Position
Device class
Class I (low risk)
Regulation
21 CFR 868.6820
Specialty
Anesthesiology

Other 510(k)s with product code CCX

510(k)DeviceApplicantDecision
K943837Chin UpCCX · Traditional Edward Carden10/14/1994SE
K932305Vila-Cooke(Tm) Anesthesia PillowCCX · Traditional Sharn, Inc.10/05/1993SE
K934235Sniff Position PillowCCX · Traditional American Medical Development, Inc.10/01/1993SE
K861915Surgical Head SupportCCX · Traditional Treace Medical, Inc.05/30/1986SE
K833022Air Uterine Displacer-Aud 120CCX · Traditional Scientific Sales Intl., Inc.10/14/1983SE
K810035Prenatal Support PillowCCX · Traditional Supportech, Inc.01/23/1981SE
K801330Anspach Leg SupportCCX · Traditional The Anspach Effort, Inc.06/26/1980SE

More from The Anspach Effort, Inc.

510(k)DeviceDecision
K831582Vari-Support Neck Posture PillowIQK · Traditional 06/15/1983SE
K821836Pregnancy (W) EdgeQSB · Traditional 07/30/1982SE
K821837Vari-Support Neck Posture PillowIQK · Traditional 07/20/1982SE
K802442Low Back Posture PillowIQK · Traditional 10/31/1980SE

Questions and answers

When was Vari-Support Low Back Posture Pillow cleared by the FDA?

Vari-Support Low Back Posture Pillow (K821838) received a 510(k) decision of Substantially Equivalent on July 20, 1982, 28 days after the submission was received.

What is the product code of K821838?

The FDA product code is CCX – Support, Patient Position, a Class I (low risk) device regulated under 21 CFR 868.6820.