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ManaFlexx

Manamed, Inc. · Model MF0001-RX · UDI-DI 00850998008034

IPF Prescription

510(k) clearances

678

Adverse events (1 deaths)

Recalls

174

Facilities

Description

ManaFlexx is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

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.