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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Definition Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain.
Physical State Main components include implanted leads, implanted neurostimulator, and external programmers
Technical Method Electrical stimulation of nerves that innervate the muscle to provide chronic, intractable lower back pain relief
Target Area Nerves that innervate specific muscles groups.
Review Panel Neurology
Product CodeQLK
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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