Cleared Traditional

K911608 - GRANSTAND

K911608 is an FDA 510(k) clearance for GRANSTAND, manufactured by Prime Engineering. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K911608 · Prime Engineering · Physical Medicine device
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Apr 1991
Decision
13d
Days
Class 2
Risk

K911608 is an FDA 510(k) clearance for the GRANSTAND. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Prime Engineering (Fresno, US). The FDA issued a Cleared decision on April 23, 1991 after a review of 13 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 Prime Engineering devices

FDA 510(k) Submission Details - K911608

510(k) Number K911608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1991
Decision Date April 23, 1991
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
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 35
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K911608.
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