Cleared Traditional

THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM

K931594 · Medical Device Inspection Co., Inc. · Physical Medicine
Dec 1993
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K931594 is an FDA 510(k) clearance for the THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on December 21, 1993, 265 days after receiving the submission on March 31, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number K931594 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1993
Decision Date December 21, 1993
Days to Decision 265 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

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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