Cleared Traditional

K012345 - NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

K012345 is an FDA 510(k) clearance for NEW HEIGHTS ELECTRIC ELEVATING MANUAL W..., manufactured by Bromac Assistive Technology. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K012345 · Bromac Assistive Technology · Physical Medicine device
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Oct 2001
Decision
71d
Days
Class 2
Risk

K012345 is an FDA 510(k) clearance for the NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Bromac Assistive Technology (Lancaster, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 Bromac Assistive Technology devices

FDA 510(k) Submission Details - K012345

510(k) Number K012345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date October 03, 2001
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 25
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K012345.
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