Cleared Traditional

K012258 - COMPANION MODEL 221, 321, 421

K012258 is an FDA 510(k) clearance for COMPANION MODEL 221, manufactured by Golden Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K012258 · Golden Technologies, Inc. · Physical Medicine device
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Dec 2001
Decision
138d
Days
Class 2
Risk

K012258 is an FDA 510(k) clearance for the COMPANION MODEL 221, 321, 421. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Golden Technologies, Inc. (Old Forge, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 138 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 - K012258

510(k) Number K012258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2001
Decision Date December 03, 2001
Days to Decision 138 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
22d slower than avg
Panel avg: 116d · This submission: 138d
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 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K012258.
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
K020002 · Transworld Mobility Distribution, LLC · Mar 2002
MINI SHOPPER
K013927 · Shoprider Intl., Inc. · Jan 2002
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K013788 · Merits Health Products Co., Ltd. · Dec 2001
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
K012258 · COMPANION MODEL 221, 321, 421
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