Cleared Traditional

K091043 - POWER DRIVE CHAIR, MODEL: TMM6

K091043 is an FDA 510(k) clearance for POWER DRIVE CHAIR, manufactured by Transmotion Medical, Inc.. The device is a Class 2 Physical Medicine device with product code INK cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K091043 · Transmotion Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
28d
Days
Class 2
Risk

K091043 is an FDA 510(k) clearance for the POWER DRIVE CHAIR, MODEL: TMM6. Classified as Stretcher, Wheeled, Powered (product code INK), Class II - Special Controls.

Submitted by Transmotion Medical, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 11, 2009 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3690 - 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.

FDA 510(k) Submission Details - K091043

510(k) Number K091043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2009
Decision Date May 11, 2009
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 116d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INK Device Classification - Class 2, Special Controls

Product Code INK Stretcher, Wheeled, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3690
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 - INK Stretcher, Wheeled, Powered

All 10
Devices cleared under the same product code (INK) and FDA review panel - the closest regulatory comparables to K091043.
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K091043 · POWER DRIVE CHAIR, MODEL: TMM6
Download PDF FDA Summary Transmotion Medical, …