Cleared Traditional

K983662 - C.T.M. MOBILITY SCOOTER, MODEL # HS-686

K983662 is an FDA 510(k) clearance for C.T.M. MOBILITY SCOOTER, manufactured by Warepalmy Enterprise, LLC (Usa). The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K983662 · Warepalmy Enterprise, LLC (Usa) · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
60d
Days
Class 2
Risk

K983662 is an FDA 510(k) clearance for the C.T.M. MOBILITY SCOOTER, MODEL # HS-686. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Warepalmy Enterprise, LLC (Usa) (Phoenix, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 60 days - a notably fast clearance cycle.

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: 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 Warepalmy Enterprise, LLC (Usa) devices

FDA 510(k) Submission Details - K983662

510(k) Number K983662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1998
Decision Date December 18, 1998
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
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 173
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K983662.
AMIGO MODEL 590000
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MEGA 4
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MEGA 3
K982145 · Mega Motion, Inc. · Apr 1999
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K983663 · Warepalmy Enterprise, LLC (Usa) · Dec 1998
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
K981885 · Sunrise Medical, Inc. · Nov 1998
ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
K983405 · Aceme Technologies Intl. · Nov 1998