Cleared Traditional

K030882 - RABBIT MOBILE STANDING FRAME

K030882 is an FDA 510(k) clearance for RABBIT MOBILE STANDING FRAME, manufactured by R82 A/S. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K030882 · R82 A/S · Physical Medicine device
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Apr 2003
Decision
15d
Days
Class 2
Risk

K030882 is an FDA 510(k) clearance for the RABBIT MOBILE STANDING FRAME. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by R82 A/S (Stallings, US). The FDA issued a Cleared decision on April 4, 2003 after a review of 15 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.

FDA 510(k) Submission Details - K030882

510(k) Number K030882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2003
Decision Date April 04, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
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 49
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K030882.
HERO 1, MODEL LY-ESB220
K031621 · Comfort Orthopedic Co., Ltd. · Jan 2004
POWERSTAND STAND-UP WHEELCHAIR
K032101 · The Standing Co., Inc. · Jan 2004
COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
K031618 · Comfort Orthopedic Co., Ltd. · Dec 2003
LEVO COMBI
K030893 · Levo AG · Apr 2003
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
K021165 · Bromac Assistive Technology · Jul 2002
VERTRAN STANDING WHEELCHAIR
K011530 · Fena Design, Inc. · Oct 2001