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TrueStim

Hi-Dow International Incorporated · Model HD-08B(TSG-E1) · UDI-DI 00081009308007

ILXIRT
1
510(k) clearances
8
Adverse events
1
Recalls
7
Facilities

Description

Pulsed Electromagnetic Field Wrap, Black, lower limb wrap

Recalls

DateFirmReason
2008-09-29Regenesis Biomedical IncIn the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio f

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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.