Changsha Anxiang Medical Technology Co., Ltd.: FDA clearances and approvals
Changsha Anxiang Medical Technology Co., Ltd. has 8 FDA 510(k) clearances (first 2024, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time: 92 days. Since 2017 its median was 92 days, against 140 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 2 | 80 |
| 2025 | 6 | 94 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Changsha Anxiang Medical Technology Co., Ltd.'s cleared 510(k)s took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 5 | 5 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
Review panels
- Physical Medicine (5)
- Neurology (3)
Most recent Changsha Anxiang Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251429 | OTC 4-Channel Rechargeable TENS Unit | NUH | 2025-08-28 | 112 |
| K251706 | TENS and EMS Unit | NGX | 2025-07-30 | 57 |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | NUH | 2025-07-28 | 102 |
| K250759 | 3 in 1 TENS UNIT | NGX | 2025-06-13 | 92 |
| K243763 | Wireless TENS & EMS Unit | NGX | 2025-03-12 | 96 |
| K243511 | OTC TENS & EMS Unit | NGX | 2025-02-10 | 90 |
| K242787 | Tens & Ems Device (TU1080) | NGX | 2024-12-18 | 93 |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | NUH | 2024-11-04 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Changsha Anxiang Medical Technology Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Changsha Anxiang Medical Technology Co., Ltd. have?
Changsha Anxiang Medical Technology Co., Ltd. has 8 FDA 510(k) clearances (first 2024, latest 2025), across 2 product codes in 2 review panels.
How long does FDA take to clear Changsha Anxiang Medical Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Changsha Anxiang Medical Technology Co., Ltd.'s cleared 510(k)s is 92 days. Since 2017: 92 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does Changsha Anxiang Medical Technology Co., Ltd. make?
Its most frequent FDA product codes are NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 5); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3).
Has Changsha Anxiang Medical Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Changsha Anxiang Medical Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 8 Changsha Anxiang Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NGX, Changsha Anxiang Medical Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.