Cleared Traditional

K931594 - THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM

K931594 is the FDA 510(k) clearance for THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM by Medical Device Inspection Co., Inc.. It is a Class 2 Physical Medicine device (product code IOQ) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

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

K931594 is an FDA 510(k) clearance for the THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on December 21, 1993 after a review of 265 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Device Inspection Co., Inc. devices

Submission Details

510(k) Number K931594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 115d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IOQ Bed, Flotation Therapy, Powered

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