Cleared Traditional

COMPACT WHEELCHAIR PLATFORM (K101723) - FDA 510(k) Clearance

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

K101723 · Design Specific Fletcher · Physical Medicine device
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Dec 2010
Decision
188d
Days
Class 2
Risk

K101723 is an FDA 510(k) clearance for the COMPACT WHEELCHAIR PLATFORM. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Design Specific Fletcher (Ringmer East Sussex, GB). The FDA issued a Cleared decision on December 23, 2010 after a review of 188 days - an extended review 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: 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 Design Specific Fletcher devices

Submission Details

510(k) Number K101723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2010
Decision Date December 23, 2010
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.