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U.S. Department of Health and Human Services

Product Classification
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Device orthosis, pneumatic structure, rigid
Regulation Description Rigid pneumatic structure orthosis.
Definition Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIPO
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Regulation Number 890.3610
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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