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510(k) K882092

CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM by Gaymar Industries, Inc. — Product Code FNM

K882092 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 13, 1988. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 13, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type

Other clearances by Gaymar Industries, Inc.

  • K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (Jan 20, 2011)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (Apr 30, 1997)
  • K963067 — SOF. PRESS EPC 51 SYSTEM (Jan 28, 1997)
  • K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (Aug 9, 1996)
  • K942881 — TC 3000 (May 23, 1995)
  • K930345 — TC2000 POWER UNIT AND ACCESSORIES (Aug 6, 1993)
  • K914921 — SCM-3 AND ACCESSORIES (Mar 12, 1992)
  • K914805 — TC-1000, TC-1050 SYSTEM (Jan 7, 1992)
  • K914851 — CLA-1400 SYSTEM (Nov 13, 1991)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (Feb 20, 1998)
  • K974319 — MIGHTY AIR (Jan 22, 1998)
  • K972022 — ZAK-2000 (Jan 22, 1998)
  • K974070 — PHYSIO/1000 (Jan 6, 1998)
  • K972549 — SIMPULSE (Nov 18, 1997)
  • K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (Nov 7, 1997)
  • K955243 — BARIAIR (Oct 23, 1997)
  • K970468 — KT AIR BED (Sep 5, 1997)
  • K965207 — RID-DECUBE II (Aug 21, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (Jul 31, 1997)

FDA data resources