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510(k) K926402

COMFORT CARE LOW AIR LOSS THERAPY BED by Ch Administration, Inc. — Product Code INX

K926402 is an FDA 510(k) premarket notification submitted by Ch Administration, Inc. for the device "COMFORT CARE LOW AIR LOSS THERAPY BED". The FDA issued a decision of Substantially Equivalent on March 24, 1993. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Ch Administration, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1993
Date Received
December 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

Other clearances by Ch Administration, Inc.

  • K953196 — CARDIO-SYSTEMS PRO-OP (November 8, 1995)
  • K926403 — PRO-2000 LOW AIR LOSS THERAPY BED (July 30, 1993)

Other clearances for product code INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K964223 — CLINITRON RITE-HITE (May 28, 1997)
  • K943385 — CLINITRON ELEXIS (February 27, 1995)
  • K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY (February 7, 1995)
  • K931168 — X-20 AIR SUPPORT BED (February 17, 1994)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K924973 — DYLNAMEDICS A.S.A.P. (October 15, 1993)
  • K924686 — REM-AIR (February 12, 1993)
  • K920112 — CLINITRON C-II (January 24, 1992)
  • K913654 — SMITH AND DAVIS PRESSURE THERAPY SYSTEM (November 22, 1991)

FDA data resources