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U.S. Department of Health and Human Services

Product Classification

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Device wheelchair, mechanical
Regulation Description Mechanical wheelchair.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIOR
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.3850
Device Class 1
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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