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K Number
K221384
Device Name
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Manufacturer
Hivox Biotek Inc.
Date Cleared
2022-06-11

(29 days)

Product Code
NUH,IRT,NGX
Regulation Number
882.5890
Type
Special
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).