Cleared Traditional

K984565 - TMC-EASY-302

K984565 is an FDA 510(k) clearance for TMC-EASY-302, manufactured by Tmc Magnetics & Machinery Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K984565 · Tmc Magnetics & Machinery Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
420d
Days
Class 2
Risk

K984565 is an FDA 510(k) clearance for the TMC-EASY-302. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Tmc Magnetics & Machinery Corp. (Great Neck, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Tmc Magnetics & Machinery Corp. devices

FDA 510(k) Submission Details - K984565

510(k) Number K984565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date February 16, 2000
Days to Decision 420 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
305d slower than avg
Panel avg: 115d · This submission: 420d
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 K984565.
LASER 3 SPSC300
K003058 · Pride Mobility Products Corp. · Mar 2001
LASER 4SPSC340
K003059 · Pride Mobility Products Corp. · Mar 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
GLORY
K994127 · Pillar Technology, Inc. · Feb 2000
ELECTRIC MOBILITY CAVALIER SCOOTERS
K991281 · Electric Mobility Corp. · Oct 1999
ACTIVA
K991132 · Hoveround Corp. · Oct 1999