Cleared Traditional

K931349 - TMR-670

K931349 is an FDA 510(k) clearance for TMR-670, manufactured by Pride Health Care, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K931349 · Pride Health Care, Inc. · Physical Medicine device
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Jul 1993
Decision
127d
Days
Class 2
Risk

K931349 is an FDA 510(k) clearance for the TMR-670. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Pride Health Care, Inc. (Pittston, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - 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 Pride Health Care, Inc. devices

FDA 510(k) Submission Details - K931349

510(k) Number K931349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date July 22, 1993
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
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 - INO Chair, Positioning, Electric

All 16
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K931349.
PREVENT I
K973373 · The Buzzz Corp. · Feb 1998
ELECTRIC SEAT LIFT CHAIR
K961663 · Ken Kemmerer · May 1996
TMR48
K953342 · Pride Health Care, Inc. · Sep 1995
TREATMENT TABLE, MODEL #825-100
K930262 · Biodan Medical Systems, Ltd. · Mar 1993
COMFORT+LIFT CHAIR
K864366 · Invacare Corp. · Dec 1986
COMFORT + LIFT
K852812 · Invacare Corp. · Nov 1985