Product Classification

• 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 Code: SDO
• 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

Recognized Consensus Standard

• 17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

Third Party Review

Not Third Party Eligible