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U.S. Department of Health and Human Services

Product Classification

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Device massager, powered inflatable tube
Regulation Description Powered inflatable tube massager.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIRP
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5650
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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