Cleared Traditional

STAGE ZERO AIR FLOTATION BED

K905053 · Lake Medical Products, Inc. · Physical Medicine
Nov 1990
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K905053 is an FDA 510(k) clearance for the STAGE ZERO AIR FLOTATION BED, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 26, 1990, 18 days after receiving the submission on November 8, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number K905053 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1990
Decision Date November 26, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOQ — Bed, Flotation Therapy, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5170

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