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Found 4 results
510(k) Data Aggregation
K Number
K132998Device Name
WANDY SELF-ADHESIVE ELECTRODES
Manufacturer
WANDY RUBBER INDUSTRIAL CO., LTD
Date Cleared
2013-12-20
(87 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
WANDY RUBBER INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin, for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
Device Description
Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
The Wandy Self-adhesive Electrodes transmits electrical current to patient skin, the electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.
The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.
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K Number
K031174Device Name
BODY SIGNAL ECG ELECTRODE
Manufacturer
WANDY RUBBER INDUSTRIAL CO., LTD
Date Cleared
2003-07-10
(87 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
WANDY RUBBER INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Body Signal ECG Electrodes are designed for use in general electrocardiograph procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.
Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.
Device Description
Not Found
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K Number
K002219Device Name
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
Manufacturer
WANDY RUBBER INDUSTRIAL CO., LTD
Date Cleared
2001-02-02
(193 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
WANDY RUBBER INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002227Device Name
WANDY SILICONE CONDUCTIVE RUBBER PAD
Manufacturer
WANDY RUBBER INDUSTRIAL CO., LTD
Date Cleared
2001-02-02
(193 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
WANDY RUBBER INDUSTRIAL CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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