Cleared Traditional

K970543 - BOBCAT DX

K970543 is an FDA 510(k) clearance for BOBCAT DX, manufactured by Quest Enabling Designs , Ltd.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K970543 · Quest Enabling Designs , Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
134d
Days
Class 2
Risk

K970543 is an FDA 510(k) clearance for the BOBCAT DX. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Quest Enabling Designs , Ltd. (Fareham, Hampshire, GB). The FDA issued a Cleared decision on June 26, 1997 after a review of 134 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K970543

510(k) Number K970543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1997
Decision Date June 26, 1997
Days to Decision 134 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 116d · This submission: 134d
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 64
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K970543.
LEVO MOBIL LCM
K963817 · Levo USA · Dec 1997
LEVO COMPACT-EASY LCE
K973951 · Levo USA · Dec 1997
LEVO ACTIVE-EASY LAE
K971873 · Levo USA · Jul 1997
LEVO COMPACT LC
K963816 · Levo USA · Oct 1996
SUPERSTAND STAND-UP WHELLCHAIR
K962278 · The Standing Co., Inc. · Oct 1996
CHIEF STANDUP WHEELCHAIR
K940852 · Redman, Inc. · Feb 1995
K970543 · BOBCAT DX
Download PDF FDA Summary Quest Enabling Design…