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510(k) K760613

FLOTATION UNIT, CHAIR by Medpro, Inc. — Product Code KIC

K760613 is an FDA 510(k) premarket notification submitted by Medpro, Inc. for the device "FLOTATION UNIT, CHAIR". The FDA issued a decision of Substantially Equivalent on October 14, 1976. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Medpro, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1976
Date Received
September 10, 1976
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 Medpro, Inc.

  • K772062 — NEONATAL FLOTATION SYSTEM (November 15, 1977)
  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)
  • K760870 — HEEL/ELBOW FLOTATION CUSHION (November 1, 1976)

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