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510(k) Data Aggregation
K Number
K220997Device Name
Wireless TENS/EMS, Bruno, Aela
Manufacturer
Date Cleared
2022-09-01
(150 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
ZMI Elecronics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS:
[RS-18, RS-28, RS-38 models]: 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.
[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:
[RS-18. RS-28]: To stimulate healthy muscles in order to improve and facilitate muscle performance.
Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult
Device Description
"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.
The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.
The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions.
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