Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Body Clock Health Care, Ltd. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
266 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091045SMART TENS, MODEL: D-BC05TBody Clock Health Care, Ltd.2009-12-182490
K041359BODY CLOCK STIMPLUS AND STIMPLUS PROBody Clock Health Care, Ltd.2004-08-20910
K022849BODY CLOCK TENS N' TONEBody Clock Health Care, Ltd.2003-05-202660
K021846804SIII; 804W; LIBRA TENS; 410; S-TENS IIBody Clock Health Care, Ltd.2002-11-221700
K022731V TENS PLUSBody Clock Health Care, Ltd.2002-11-14900
K022493EMS 400Body Clock Health Care, Ltd.2002-10-11740
K022076FIRST CHOICE & FIRST CHOICE PLUSBody Clock Health Care, Ltd.2002-09-24900

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda