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U.S. Department of Health and Human Services

Product Classification

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Device transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation
Definition A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.
Physical State A transcutaneous electrical spine stimulator includes a stimulator that can set or receive stimulation parameters and send that to electrodes to be placed externally over the spine.
Technical Method A stimulator generates and delivers electrical stimulation to the intended area through stimulation electrodes.
Target Area Patient's skin over the spine
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeSDO
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5851
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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