FDA-Device2025-06-25Class III
AcoSound. Model Number: LW12-BTE-M
HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.
Hazard
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 "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.
Sold states
US Nationwide distribution in the state of New York.
Affected count
120 units
Manufactured in
No.2 Building Room 401, No. 1390 Cangxing Street, Yuhang, Hangzhou, N/A, China
Products
AcoSound. Model Number: LW12-BTE-M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2025Don't want to check this manually?
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