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Blue Deer Medical Equipment (guangdong) Co., Ltd. · Model XTS-AISW-D1 · UDI-DI 06980134820245

QUG
0
510(k) clearances
15
Adverse events
1
Recalls
90
Facilities

Description

This is a Personal Sound Amplifier (PSAP), a consumer electronic device designed to amplify ambient sound and audio for daily indoor and outdoor scenarios. It is used purely for general sound enhancement in daily life, not for any medical related purpose.

Recalls

DateFirmReason
2025-04-25HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manu

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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.