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Pure Impact

SOFWAVE MEDICAL LTD · Model KT00040 · UDI-DI 07290018152164

NGX Prescription

510(k) clearances

Adverse events

Recalls

207

Facilities

Description

Powered Muscle Stimulator (EMS) KIT. The KIT contains 3 components (all individually registered in GUDID): (SN) FG00013 with UDI: 07290018152133 (SN) FG00014 with UDI: 07290018152140 (SN) FG00015 with UDI: 17290018152154

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.