Home / 510(k) Clearances / K810035

510(k) K810035

PRENATAL SUPPORT PILLOW by Supportech, Inc. — Product Code CCX

K810035 is an FDA 510(k) premarket notification submitted by Supportech, Inc. for the device "PRENATAL SUPPORT PILLOW". The FDA issued a decision of Substantially Equivalent on January 23, 1981. The device falls under product code CCX (Support, Patient Position), a Class I device regulated under 21 CFR 868.6820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1981
Date Received
January 9, 1981
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 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)
  • K821838 — VARI-SUPPORT LOW BACK POSTURE PILLOW (July 20, 1982)
  • K801330 — ANSPACH LEG SUPPORT (June 26, 1980)

FDA data resources