FDA applicant

Boditech Med, Inc.

Chuncheon-Si, Gang-Won-Do, KR2 decisions2014–20170 recalls

FDA records 2 decisions for Boditech Med, Inc. (Chuncheon-Si, Gang-Won-Do, KR) from 2014 to 2017: 2 510(k) clearances. Most are in product codes OOX (Automated Occult Blood Analyzer) and JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Boditech Med, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Boditech Med, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Boditech Med, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Boditech”

FDA records each applicant name separately; these may or may not be the same firm.

Boditech Diagnostics, Inc. 1

Boditech Med, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Boditech”