FDA applicant

Hand Biomechanics Lab, Inc.

Sacramento, CA9 decisions1994–20251 recall

FDA records 9 decisions for Hand Biomechanics Lab, Inc. (Sacramento, CA) from 1994 to 2025: 9 510(k) clearances. Most are in product codes JEC (Component, Traction, Invasive) and HRX (Arthroscope). Its devices cite 10 predicates, 4 of them its own earlier devices. 1 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, orthopedic panel, where it files most

How often FDA has decided Hand Biomechanics Lab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hand Biomechanics Lab, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hand Biomechanics Lab, 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 “Hand”

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

Hand Innovations, Inc. 17 Hand Care, Inc., Ltd. 1 The Hand Biomechanics Research Laboratory 1

Hand Biomechanics Lab, 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?

What has been recalled?

Other applicant names beginning “Hand”