Home / 510(k) Clearances / K974319

510(k) K974319

MIGHTY AIR by Wheelchairs of Kansas — Product Code FNM

K974319 is an FDA 510(k) premarket notification submitted by Wheelchairs of Kansas for the device "MIGHTY AIR". The FDA issued a decision of Substantially Equivalent on January 22, 1998. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Wheelchairs of Kansas has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1998
Date Received
November 17, 1997
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 Wheelchairs of Kansas

  • K970743 — BCW POWER ADVANTAGE WHEELCHAIR (April 30, 1997)
  • K961514 — BCW ADVANTAGE WHEELCHAIR (May 7, 1996)
  • K945047 — BCW 600 POWER WHEELCHAIR (August 11, 1995)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K972022 — ZAK-2000 (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)
  • K954320 — MODIFIED PEDIKAIR (July 18, 1997)

FDA data resources