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U.S. Department of Health and Human Services

Product Classification

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Device elevator, wheelchair, portable
Regulation Description Wheelchair elevator.
Definition A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeING
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.3930
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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