Cleared Traditional

K953342 - TMR48

K953342 is an FDA 510(k) clearance for TMR48, 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 59-day FDA review.

K953342 · Pride Health Care, Inc. · Physical Medicine device
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Sep 1995
Decision
59d
Days
Class 2
Risk

K953342 is an FDA 510(k) clearance for the TMR48. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Pride Health Care, Inc. (West Wyoming, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pride Health Care, Inc. devices

FDA 510(k) Submission Details - K953342

510(k) Number K953342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1995
Decision Date September 08, 1995
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 K953342.
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K930262 · Biodan Medical Systems, Ltd. · Mar 1993
COMFORT+LIFT CHAIR
K864366 · Invacare Corp. · Dec 1986