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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 Office of 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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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