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510(k) Data Aggregation
K Number
K232439Device Name
Electrical Stimulator System
Manufacturer
Gymmax Technology Shenzen Co., Ltd.
Date Cleared
2024-03-21
(220 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Gymmax Technology Shenzen Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (TENS 1 and TENS 2)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PMS (STIM1 STIM2 STIM3 and STIM4)
To stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
The Electrical Stimulator System delivers electric pulses to the user's body areas in shoulder, waist, back, arm, and leg. The portable and compact device has multiple modes frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electical Muscle Stimulation (EMS). It includes the operating elements of an M button, intensity increase button, intensity decrease button, and can be attached and detached to electrodes.
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K Number
K192201Device Name
Electrical Stimulator System
Manufacturer
Gymmax Technology Shenzen Co., Ltd.
Date Cleared
2020-06-12
(304 days)
Product Code
NUH, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Gymmax Technology Shenzen Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS (Modes 1 and 6)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS (Modes 2, 3, 4 and 5)
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Device Description
The Electrical Stimulator System delivers electric pulses to the user's body areas such as the back, neck, and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electrical Muscle Stimulation (EMS). It includes the operating elements of an ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and can be attached and detached to electrodes.
The electrodes cleared include the electrode pads and electrode garments, which may be packaged separately and/or together with the subject device.
The associated accessories include: Arm Pad ( 34x56mm±2mmx2 ) * 1 Abdominal Pad(34x56mm±2mmx6) * 1 Gel Pad ( 34x56mm±2mm,produced by GMDASZ with K092546) * 8 USB Cable * 1 Operating Instruction * 1
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