DVT-4000S
FDA 510(k) K203417 · Daesung Maref Co., Ltd.
510(k) numberK203417
Submission
- Device name
- DVT-4000S
- Applicant
- Daesung Maref Co., Ltd.
Gunpo-Si, KR - Received
- November 19, 2020
- Decision date
- March 28, 2021
- 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
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| 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 |
|---|---|---|
| K231437 | LF900IRP · Special | 07/19/2023SE |
| K202395 | SP-1000, SP-2000IRP · Traditional | 09/01/2021SE |
| K203498 | LX9maxIRP · Traditional | 07/02/2021SE |
| K203019 | LF900IRP · Traditional | 06/22/2021SE |
| K203353 | Dvt-ProJOW · Special | 04/22/2021SE |
| K203016 | DVT-2600JOW · Special | 12/05/2020SE |
| K160178 | Lympha-Flow(LF1200)IRP · Special | 01/11/2017SE |
| K160180 | Intermittent Pneumatic Compression systemJOW · Special | 11/03/2016SE |
| K150980 | Venous Assist SystemJOW · Traditional | 05/12/2016SE |
| K150033 | Air Compressible Limb Therapy SystemIRP · Special | 04/20/2015SE |
Questions and answers
When was DVT-4000S cleared by the FDA?
DVT-4000S (K203417) received a 510(k) decision of Substantially Equivalent on March 28, 2021, 129 days after the submission was received.
What is the product code of K203417?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.