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U.S. Department of Health and Human Services

Product Classification
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Device injectable for thermal treatment of musculoskeletal pain
Definition An injectable for thermal treatment of musculoskeletal pain is an injectable device intended to inhibit sensory nerve signaling through exchange of thermal energy (e.g., cold temperatures). The device is injected into the extraneural space of the target nerve.
Physical State Flowable injectable
Technical Method Injection of the device into the extraneural space of the target sensory nerve inhibits sensory nerve signaling through exchange of thermal energy.
Target Area Nerve
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeSJA
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3048
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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