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510(k) Data Aggregation
K Number
K190700Device Name
ELECTRODES PAD
Manufacturer
Date Cleared
2019-06-14
(88 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Bestpad Technology Development Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.
Device Description
ELECTRODES PAD transmit electrical current to patient skin, the electrical current is first transmitted via the snap button or lead wire then transmitted to the conductive hydrogel which is adhered to patient skin. ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only. And the PAD is designed for single-patient and multiple application use. The leadwire type electrode and snap type electrode both have six basic components. Both models are composed of an insulation backing layer, a double sides adhesive tape, conducting film, hydrogel and plastic film. The construction different between both is leadwire and snap.
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