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510(k) K823903

RUBBER INFLATABLE RING by Duro-Med Ind., Inc. — Product Code KIC

K823903 is an FDA 510(k) premarket notification submitted by Duro-Med Ind., Inc. for the device "RUBBER INFLATABLE RING". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Duro-Med Ind., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 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 Duro-Med Ind., Inc.

  • K803177 — MOIST HEAT PACK (December 31, 1980)

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