Cleared Traditional

K925652 - UNIVERSAL WHEELCHAIR LIFT

K925652 is an FDA 510(k) clearance for UNIVERSAL WHEELCHAIR LIFT, manufactured by Better Life Medical Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K925652 · Better Life Medical Technologies, Inc. · Physical Medicine device
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Jun 1993
Decision
227d
Days
Class 2
Risk

K925652 is an FDA 510(k) clearance for the UNIVERSAL WHEELCHAIR LIFT. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Better Life Medical Technologies, Inc. (Princeton, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 227 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 Better Life Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K925652

510(k) Number K925652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date June 24, 1993
Days to Decision 227 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 115d · This submission: 227d
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 21
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K925652.
ELECTRIC SEAT LIFT CHAIR
K961663 · Ken Kemmerer · May 1996
TMR48
K953342 · Pride Health Care, Inc. · Sep 1995
TMR-670
K931349 · Pride Health Care, Inc. · Jul 1993
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