Jkh Health Co., Ltd.: FDA clearances and approvals
Jkh Health Co., Ltd. has 10 FDA 510(k) clearances (first 2016, latest 2025), across 5 product codes in 4 review panels. Median 510(k) review time: 134 days. Since 2017 its median was 119 days, against 160 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 149 |
| 2017 | 1 | 217 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 119 |
| 2021 | 1 | 118 |
| 2022 | 1 | 599 |
| 2023 | 1 | 336 |
| 2024 | 2 | 36 |
| 2025 | 2 | 234 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Jkh Health Co., Ltd.'s cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | 3 | 3 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
- Physical Medicine (4)
- Neurology (3)
- Cardiovascular (2)
- General Hospital (1)
Most recent Jkh Health Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253150 | Cryon-X Cold Compression | IRP | 2025-10-24 | 29 |
| K240788 | Ultrasound Stimulator | IMI | 2025-06-04 | 439 |
| K240986 | Cold Compression | IRP | 2024-05-01 | 21 |
| K240011 | Lymphedema Compression | JOW | 2024-02-23 | 52 |
| K223541 | Cold/Hot Compression | IRP | 2023-10-27 | 336 |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | FLL | 2022-11-28 | 599 |
| K202839 | Overlapped Compression Therapy | JOW | 2021-01-21 | 118 |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | NUH | 2020-07-01 | 119 |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | NUH | 2017-04-14 | 217 |
| K153520 | Electronic Pulse Stimulator | NUH | 2016-05-05 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Jkh Health 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 Jkh Health Co., Ltd. have?
Jkh Health Co., Ltd. has 10 FDA 510(k) clearances (first 2016, latest 2025), across 5 product codes in 4 review panels.
How long does FDA take to clear Jkh Health Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Jkh Health Co., Ltd.'s cleared 510(k)s is 134 days. Since 2017: 119 days, versus 160 days for all cleared 510(k)s in the same product codes.
What devices does Jkh Health Co., Ltd. make?
Its most frequent FDA product codes are IRP (Massager, Powered Inflatable Tube, 3); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3); JOW (Sleeve, Limb, Compressible, 2).
Has Jkh Health Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jkh Health Co., Ltd. Related entities may recall under other names.
Next steps
- See all 10 Jkh Health Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IRP, Jkh Health 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.