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7E Wellness

SYRMA JOHARI MEDTECH LIMITED · Model MY-O-CALME · UDI-DI 08908008085208

QJQ
1
510(k) clearances
39
Adverse events
1
Recalls
13
Facilities

Recalls

DateFirmReason
2023-04-06Fisher Wallace Laboratories Inc.If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.