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510(k) K821838

VARI-SUPPORT LOW BACK POSTURE PILLOW by Body Therapeutics, Inc. — Product Code CCX

K821838 is an FDA 510(k) premarket notification submitted by Body Therapeutics, Inc. for the device "VARI-SUPPORT LOW BACK POSTURE PILLOW". The FDA issued a decision of Substantially Equivalent on July 20, 1982. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820. Body Therapeutics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
June 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Patient Position
Device Class
Class I
Regulation Number
868.6820
Review Panel
AN
Submission Type

Other clearances by Body Therapeutics, Inc.

  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K821836 — PREGNANCY (W) EDGE (July 30, 1982)
  • K821837 — VARI-SUPPORT NECK POSTURE PILLOW (July 20, 1982)
  • K802442 — LOW BACK POSTURE PILLOW (October 31, 1980)

Other clearances for product code CCX

  • K943837 — CHIN UP (October 14, 1994)
  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K934235 — SNIFF POSITION PILLOW (October 1, 1993)
  • K861915 — SURGICAL HEAD SUPPORT (May 30, 1986)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K810035 — PRENATAL SUPPORT PILLOW (January 23, 1981)
  • K801330 — ANSPACH LEG SUPPORT (June 26, 1980)

FDA data resources