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510(k) K820236

WATER FLOATATION PAD by Gottfried Medical, Inc. — Product Code KIC

K820236 is an FDA 510(k) premarket notification submitted by Gottfried Medical, Inc. for the device "WATER FLOATATION PAD". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Gottfried Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
January 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cushion, Flotation
Device Class
Class I
Regulation Number
890.3175
Review Panel
PM
Submission Type

Other clearances by Gottfried Medical, Inc.

  • K010675 — ENSIL FABRIC (May 30, 2001)

Other clearances for product code KIC

  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K953352 — PROTEAM CUSHION (November 29, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)
  • K950085 — MULTICURE(R) S GEL PAD (July 13, 1995)
  • K945667 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (February 21, 1995)
  • K941858 — GEL CUSHION (May 5, 1994)
  • K911843 — ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (May 30, 1991)
  • K872739 — SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (July 30, 1987)
  • K864109 — C' AIRECUSH SEAT CUSHION (November 14, 1986)
  • K864108 — PUSH CUSH (November 14, 1986)

FDA data resources