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PROFILE EMS

BODY CLOCK HEALTH CARE LIMITED · Model EM-PROFILE_EMS · UDI-DI 05060079210347

IPF Prescription

510(k) clearances

678

Adverse events (1 deaths)

Recalls

174

Facilities

Description

The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm; - Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation; - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Recalls

Date	Firm	Reason
2023-11-03	Liberty Medical Solutions, LLC	The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2011-06-22	eSwallow USA LLC	It was discovered that the firm was distributing medical devices without FDA approval.
2009-01-25	Zynex Medical, Inc.	Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
2008-06-11	International Rehabilitative Sciences, Inc.	The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.