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U.S. Department of Health and Human Services

Product Classification
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Device external upper limb tremor stimulator
Regulation Description External upper limb tremor stimulator.
Definition An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.
Physical State Stimulator and wrist band
Technical Method External electrical stimulator
Target Area Wrist
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQBC
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5897
Device Class 2
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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