Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Jiantuo Electronics Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, J | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-12-31 | 93 | 0 |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-11 | 90 | 0 |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-09 | 119 | 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