Lymphedema Compression
FDA 510(k) K240011 · Jkh Health Co., Ltd.
510(k) numberK240011
Submission
- Device name
- Lymphedema Compression
- Applicant
- Jkh Health Co., Ltd.
Shenzhen, CN - Received
- January 2, 2024
- Decision date
- February 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
Other 510(k)s with product code JOW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
| K250242 | Compression Therapy Device (LGT-2202DVT)JOW · Traditional | Guangzhou Longest Medical Technology Co., Ltd. | 04/24/2026SE |
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | Shenzhen Comen Medical Instruments Co.,Ltd | 12/08/2025SE |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
More from Manamed, LLC
| 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 |
| K223541 | Cold/Hot CompressionIRP · Traditional | 10/27/2023SE |
| 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 Lymphedema Compression cleared by the FDA?
Lymphedema Compression (K240011) received a 510(k) decision of Substantially Equivalent on February 23, 2024, 52 days after the submission was received.
What is the product code of K240011?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.