Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Well Brain International , Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202653 | Gymform Total ABS | Well Brain International , Ltd. | 2021-01-15 | 123 | 0 |
| K142055 | GYMFORM ABS & CORE | Well Brain International , Ltd. | 2015-05-11 | 286 | 0 |
| K130074 | GYMFORM ABS-A-ROUND | Well Brain International , Ltd. | 2013-08-15 | 213 | 0 |
| K111781 | GYMFORM DUAL FLEX BELT MODEL WB-162 | Well Brain International , Ltd. | 2012-07-11 | 383 | 0 |
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