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HealthmateForever

HEALTHMATE INTERNATIONAL,LLC · Model CT15ab · UDI-DI 00817856020522

NGX
10
510(k) clearances
99
Adverse events
3
Recalls
207
Facilities

Recalls

DateFirmReason
2021-01-13BEMER INT. AGThere 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.
2013-05-23Pinook-UsaFailure to submit a premarket submission and gain approval of a medical device.
2013-05-23Pinook-UsaFailure 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.