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ManaFlexx 2 Electrodes - 10 pack

Manamed, Inc. · Model MFELP10 · UDI-DI 00810113683232

NGX NUH NYN GZJ IPF Prescription

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

ManaFlexx 2 is the only NMES device designed for ease of use. 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. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions Completely portable Can be placed anywhere treatment is desired Battery operated Reusable - simply replace pads and batteries

Recalls

Date	Firm	Reason
2021-01-13	BEMER INT. AG	There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.
2013-05-23	Pinook-Usa	Failure to submit a premarket submission and gain approval of a medical device.
2013-05-23	Pinook-Usa	Failure to submit a premarket submission and gain approval of a medical device.

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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.