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WELLlife™

Model WFOB-OTC-1BX · WONDFO USA CO., LTD. · DI 00816862025972

KHE — Reagent, Occult Blood · Class II · 21 CFR 864.6550

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222019-08: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device08100107080803050905
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0802
2020-1001
2021-0102
2021-0702
2021-0801
2022-0801
2024-0301
2025-0501
2025-0901
2026-0501
This device (reports/month)Average device in KHE (reports/device/month)

Regulatory clearances

  • K162333 SESE 2017-05-14 (k number procode)

Predicate lineage

K162333 — cites (transitively): K110309 (d1), K070660 (d2)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — WONDFO USA CO., LTD.

  • VAI 2018-05-11 Wondfo USA Co Ltd · 4 citations
  • VAI 2018-05-11 Wondfo USA Co Ltd · 4 citations