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DualPulse Compact

Manamed, Inc. · Model DPC · UDI-DI 00810113683379

NGX NUH NYN GZJ IPF Prescription

510(k) clearances

100

Adverse events

Recalls

214

Facilities

Description

The DualPuse Compact 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.

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.