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FDA-Device2026-02-11Class II

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Changchun Wancheng Bio-Electron Co., Ltd.
Hazard
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
3,300
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2026

Original summary

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 3,300

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