Cold/Hot Compression
FDA 510(k) K223541 · Jkh Health Co., Ltd.
510(k) numberK223541
Submission
- Device name
- Cold/Hot Compression
- Applicant
- Jkh Health Co., Ltd.
Shenzhen, CN - Received
- November 25, 2022
- Decision date
- October 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
Other 510(k)s with product code IRP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260944 | ManaCold Compression SystemIRP · Traditional | Manamed, LLC | 08/12/2026SE |
| K260529 | Air Compression Massager (HY-1165)IRP · Traditional | Xiamen High Top Electronic Technology Co., Ltd. | 07/27/2026SE |
| K260948 | Air Compression Massager (EP30B001 I)IRP · Traditional | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 07/24/2026SE |
| K253919 | Cryo And Thermo Therapy SystemIRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 06/10/2026SE |
| K252396 | Cryo Sport 2.0 (AVA 501)IRP · Traditional | Avanutri Equipamentos DE Saúde | 05/29/2026SE |
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…IRP · Traditional | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 05/05/2026SE |
| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 04/30/2026SE |
| K252386 | Hot and Cold Compression System (A02-C-032)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/03/2026SE |
| K253076 | Cryopush Cold Compression Device (A02-P-001)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/02/2026SE |
| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253150 | Cryon-X Cold CompressionIRP · Special | 10/24/2025SE |
| K240788 | Ultrasound StimulatorIMI · Traditional | 06/04/2025SE |
| K240986 | Cold CompressionIRP · Special | 05/01/2024SE |
| K240011 | Lymphedema CompressionJOW · Traditional | 02/23/2024SE |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304FLL · Traditional | 11/28/2022SE |
| K202839 | Overlapped Compression TherapyJOW · Traditional | 01/21/2021SE |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus PatchNUH · Special | 07/01/2020SE |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUH · Traditional | 04/14/2017SE |
| K153520 | Electronic Pulse StimulatorNUH · Traditional | 05/05/2016SE |
Questions and answers
When was Cold/Hot Compression cleared by the FDA?
Cold/Hot Compression (K223541) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 336 days after the submission was received.
What is the product code of K223541?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.