Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Johari Digital Healthcare , Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
227 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131291 | TORC BODY | Johari Digital Healthcare , Ltd. | 2013-06-14 | 39 | 0 |
| K112351 | ULTRA BEAUTY | Johari Digital Healthcare , Ltd. | 2012-03-30 | 227 | 0 |
| K102190 | WINSTIM | Johari Digital Healthcare , Ltd. | 2011-03-17 | 226 | 0 |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | Johari Digital Healthcare , Ltd. | 2009-05-29 | 142 | 0 |
| K062439 | POWERTONE, MODEL PT-11 | Johari Digital Healthcare , Ltd. | 2007-01-08 | 140 | 0 |
| K060246 | INFREX | Johari Digital Healthcare , Ltd. | 2006-05-05 | 94 | 0 |
| K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL I | Johari Digital Healthcare , Ltd. | 2002-12-20 | 14 | 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