Cleared Traditional

K012792 - C.T.M. MOBITIY SCOOTER MODEL #HS-360

K012792 is an FDA 510(k) clearance for C.T.M. MOBITIY SCOOTER MODEL #HS-360, 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 65-day FDA review.

K012792 · Warepalmy Enterprise, LLC (Usa) · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
65d
Days
Class 2
Risk

K012792 is an FDA 510(k) clearance for the C.T.M. MOBITIY SCOOTER MODEL #HS-360. 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 October 24, 2001 after a review of 65 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.

FDA 510(k) Submission Details - K012792

510(k) Number K012792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2001
Decision Date October 24, 2001
Days to Decision 65 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
51d faster than avg
Panel avg: 116d · This submission: 65d
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 351
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K012792.
SNAZZY2
K011473 · Shoprider Intl., Inc. · Nov 2001
SOVEREIGN
K011476 · Shoprider Intl., Inc. · Oct 2001
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012791 · Warepalmy Enterprise, LLC (Usa) · Oct 2001
EASYTRAVEL
K012592 · Tzora Active Systems , Ltd. · Oct 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · Merits Health Products., Inc. · Aug 2001
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011707 · Merits Medical Industries Co., Ltd. · Aug 2001
K012792 · C.T.M. MOBITIY SCOOTER MODEL #HS-360
Download PDF FDA Summary Warepalmy Enterprise,…