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U.S. Department of Health and Human Services

Product Classification

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Device vehicle, motorized 3-wheeled
Regulation Description Motorized three-wheeled vehicle.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeINI
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.3800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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