Cleared Traditional

TEH LIN POWERED WHEELCHAIR, MDG-601 (K041752) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041752 · Teh Lin Prosthetic & Orthopaedic, Inc. · Physical Medicine device
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Aug 2004
Decision
37d
Days
Class 2
Risk

K041752 is an FDA 510(k) clearance for the TEH LIN POWERED WHEELCHAIR, MDG-601. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Teh Lin Prosthetic & Orthopaedic, Inc. (Hsin Chu City, TW). The FDA issued a Cleared decision on August 5, 2004 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Teh Lin Prosthetic & Orthopaedic, Inc. devices

Submission Details

510(k) Number K041752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2004
Decision Date August 05, 2004
Days to Decision 37 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 577
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K041752.
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