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ManaFlexx 2

Manamed, Inc. · Model MF002-RX · UDI-DI 00850998008089

NGX NUH NYN GZJ IPF Prescription

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

The ManaFlexx 2 delivers electric pulse generated to the user’s body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. For Prescription Use: TENS: ManaFlexx2 (MF002-RX) is intended for the following use:- Symptomatic relief and management of chronic, intractable pain- Adjunctive treatment for post-surgical and post-trauma acute pain- Relief of pain associated with arthritis PMS/NMES: ManaFlexx2 (MF002-RX) is intended for the following use:- Temporary relaxation of muscle spasm- Prevention or retardation of disuse atrophy- Muscle re-education- Maintaining or increasing range of motion- Increase of local blood flow in the treatment area- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscle

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.