FDA Import Refusal SCS-8146885-6/12/1 — SHENZHEN BALEKA TECHNOLOGY

SHENZHEN BALEKA TECHNOLOGY — FEI 3016331794

The FDA refused shipment SCS-8146885-6/12/1 from SHENZHEN BALEKA TECHNOLOGY (China) on Feb 24, 2025. The refused product falls under Devices — DIGITAL THERAPY DEVICE TO REDUCE SLEEP DISTURBANCE FOR PSYCHIATRIC CONDITIONS. Cited charges: 118,3280,341,508

Refusal Details

Date
Feb 24, 2025
Country
China
Product Category
Devices
Product Code
84QMZ DIGITAL THERAPY DEVICE TO REDUCE SLEEP DISTURBANCE FOR PSYCHIATRIC CONDITIONS
Charges
118,3280,341,508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.