Cleared Traditional

K943337 - STANDUP WHEELCHAIR

K943337 is an FDA 510(k) clearance for STANDUP WHEELCHAIR, manufactured by Nestor Rehab Products , Ltd.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K943337 · Nestor Rehab Products , Ltd. · Physical Medicine device
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Aug 1994
Decision
28d
Days
Class 2
Risk

K943337 is an FDA 510(k) clearance for the STANDUP WHEELCHAIR. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Nestor Rehab Products , Ltd. (Westlake Village, US). The FDA issued a Cleared decision on August 9, 1994 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 890.3900 - 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 Nestor Rehab Products , Ltd. devices

FDA 510(k) Submission Details - K943337

510(k) Number K943337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date August 09, 1994
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 34
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K943337.
SUPERSTAND STAND-UP WHELLCHAIR
K962278 · The Standing Co., Inc. · Oct 1996
CHIEF STANDUP WHEELCHAIR
K940852 · Redman, Inc. · Feb 1995
CHIEF SR
K940919 · Redman, Inc. · Feb 1995
VERTICALIBRE WHEELCHAIR
K840626 · Poirier S.A. · Feb 1984
RISER STANDUP WHEELCHAIR
K832696 · Imex Medical Systems, Inc. · Sep 1983
LEVO-STAND-UP WHEELCHAIR
K790265 · Marion Laboratories, Inc. · Feb 1979