Cleared Traditional

K030758 - COACH 888

K030758 is an FDA 510(k) clearance for COACH 888, manufactured by Wheelchair & Scooter Express. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K030758 · Wheelchair & Scooter Express · Physical Medicine device
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Jul 2003
Decision
142d
Days
Class 2
Risk

K030758 is an FDA 510(k) clearance for the COACH 888. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Wheelchair & Scooter Express (Houston, US). The FDA issued a Cleared decision on July 31, 2003 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 - K030758

510(k) Number K030758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date July 31, 2003
Days to Decision 142 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
26d slower than avg
Panel avg: 116d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 353
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K030758.
TMC ELECTRICAL SCOOTER, EASY 405
K031313 · Tmc Technology Corp. · Sep 2003
TMC ELECTRICAL SCOOTER, EASY 411
K031314 · Tmc Technology Corp. · Sep 2003
TMC ELECTRICAL SCOOTER, EASY 321
K031315 · Tmc Technology Corp. · Sep 2003
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
K031309 · Kuann Dah Industry Co., Ltd. · Jul 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-120
K031272 · C.T.M. Homecare Product, Inc. · May 2003
LITTLE COACH
K030759 · Wheelchair & Scooter Express · May 2003
K030758 · COACH 888
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