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510(k) Data Aggregation
K Number
K182440Device Name
Body System
Manufacturer
A-1 Engineering
Date Cleared
2019-02-26
(172 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
A-1 Engineering
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Body System is intended for muscle conditioning to stimulate healthy muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.
Device Description
Body System (available in models: SX101 and OS2911). Both models utilize the same internal electrical components. The models differ only in the control/display features and exterior casing/dimensions. The Body System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.
The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.
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