Shenzhen, CN · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IRP | — | — | — | 3 | 2025-10-24 |
| JOW | Sleeve, Limb, Compressible | Class II | Cardiovascular | 2 | 2024-02-23 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Class II | Physical Medicine | 1 | 2025-06-04 |
| FLL | Continuous Measurement Thermometer | Class II | General Hospital | 1 | 2022-11-28 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class II | Neurology | 1 | 2020-07-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-24 | K253150 | Cryon-X Cold Compression | IRP | — | — |
| 2025-06-04 | K240788 | Ultrasound Stimulator | IMI | Class II | Physical Medicine |
| 2024-05-01 | K240986 | Cold Compression | IRP | — | — |
| 2024-02-23 | K240011 | Lymphedema Compression | JOW | Class II | Cardiovascular |
| 2023-10-27 | K223541 | Cold/Hot Compression | IRP | — | — |
| 2022-11-28 | K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | FLL | Class II | General Hospital |
| 2021-01-21 | K202839 | Overlapped Compression Therapy | JOW | Class II | Cardiovascular |
| 2020-07-01 | K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | NUH | Class II | Neurology |