Home / 510(k) Clearances / K810649

510(k) K810649

INVALID CUSHION by First Industries, Inc. — Product Code KIC

K810649 is an FDA 510(k) premarket notification submitted by First Industries, Inc. for the device "INVALID CUSHION". The FDA issued a decision of Substantially Equivalent on March 26, 1981. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. First Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1981
Date Received
March 10, 1981
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 First Industries, Inc.

  • K810651 — ORAL AIRWAYS (March 31, 1981)
  • K810652 — TUBING CONNECTORS (March 31, 1981)
  • K810654 — STOPPERLESS HOT/COLD RUBBER WATER BOTTLE (March 27, 1981)
  • K810653 — VINYL ICE BAG (March 27, 1981)
  • K810650 — CRUTCH TIPS & GRIPS (March 26, 1981)

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)
  • K864108 — PUSH CUSH (November 14, 1986)
  • K864109 — C' AIRECUSH SEAT CUSHION (November 14, 1986)

FDA data resources