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U.S. Department of Health and Human Services

Product Classification

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Device equipment, traction, powered
Regulation Description Power traction equipment.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeITH
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5900
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
Third Party Review
Accredited Persons
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