Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Changsha Anxiang Medical Technology Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
112 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-08-28 | 112 | 0 |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 | 57 | 0 |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-28 | 102 | 0 |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 | 92 | 0 |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 | 96 | 0 |
| K243511 | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-02-10 | 90 | 0 |
| K242787 | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. | 2024-12-18 | 93 | 0 |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and | Changsha Anxiang Medical Technology Co., Ltd. | 2024-11-04 | 67 | 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