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510(k) K953352

PROTEAM CUSHION by Iskra.Med — Product Code KIC

K953352 is an FDA 510(k) premarket notification submitted by Iskra.Med for the device "PROTEAM CUSHION". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
July 17, 1995
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 for product code KIC

  • K960189 — GEL-T CUSHION (February 7, 1996)
  • 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)
  • K864108 — PUSH CUSH (November 14, 1986)
  • K864109 — C' AIRECUSH SEAT CUSHION (November 14, 1986)
  • K861327 — ROHO HEEL PAD (June 2, 1986)

FDA data resources