Cleared Traditional

MIGHTY AIR

K974319 · Wheelchairs of Kansas · General Hospital
Jan 1998
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K974319 is an FDA 510(k) clearance for the MIGHTY AIR, a Mattress, Air Flotation, Alternating Pressure (Class II — Special Controls, product code FNM), submitted by Wheelchairs of Kansas (Ellis, US). The FDA issued a Cleared decision on January 22, 1998, 66 days after receiving the submission on November 17, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5550.

Submission Details

510(k) Number K974319 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1997
Decision Date January 22, 1998
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FNM — Mattress, Air Flotation, Alternating Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5550