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U.S. Department of Health and Human Services

Product Classification
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Device unit, fluidotherapy
Regulation Description Immersion hydrobath.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeLSB
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5100
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 Not Third Party Eligible
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