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Found 3 results
510(k) Data Aggregation
K Number
K222863Device Name
Garment Electrodes
Manufacturer
Tone-A-Matic International Inc.
Date Cleared
2023-02-01
(132 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Tone-A-Matic International Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include elbow, knee or back band.
Device Description
Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
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K Number
K221724Device Name
Conductive Gel
Manufacturer
Tone-A-Matic International Inc.
Date Cleared
2022-09-23
(101 days)
Product Code
GYB
Regulation Number
882.1275Why did this record match?
Applicant Name (Manufacturer) :
Tone-A-Matic International Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
Device Description
Not Found
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K Number
K143059Device Name
TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
Manufacturer
TONE-A-MATIC INTERNATIONAL INC.
Date Cleared
2015-01-26
(94 days)
Product Code
NGX, NUH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
TONE-A-MATIC INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS (Electric Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
Not Found
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