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510(k) K961159

POWERED LOW AIR LOSS MATTRESS SYSTEM by Span-America Medical Systems, Inc. — Product Code FNM

K961159 is an FDA 510(k) premarket notification submitted by Span-America Medical Systems, Inc. for the device "POWERED LOW AIR LOSS MATTRESS SYSTEM". The FDA issued a decision of Substantially Equivalent on June 14, 1996. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Span-America Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1996
Date Received
March 22, 1996
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 Span-America Medical Systems, Inc.

  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K960188 — PRESSUREGUARD: SELECTCARE (October 2, 1996)
  • K961502 — LUBRICATING JELLY, LOW VISCOSITY (July 18, 1996)
  • K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (April 25, 1996)
  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K954766 — PRESSURE GUARD ALTERNATING PRESSURE MATTRESS (January 11, 1996)
  • K953503 — PRESSUREGUARD IV (October 24, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)
  • K951112 — PRESSUREGUARD IV (June 6, 1995)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K974319 — MIGHTY AIR (January 22, 1998)
  • K974070 — PHYSIO/1000 (January 6, 1998)
  • K972549 — SIMPULSE (November 18, 1997)
  • K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (November 7, 1997)
  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
  • K965207 — RID-DECUBE II (August 21, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)

FDA data resources