VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System— 510(k) K222126

Clearance details

Applicant

Vivachek Biotech (Hangzhou) Co., Ltd.

Product code

Product code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2022-07-18

Decision date

2024-08-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou, CN

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Death

18

Injury

4,740

Malfunction

42,679

Other

6

Total

47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →