Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5800](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5800) → JOW — Sleeve, Limb, Compressible # JOW · Sleeve, Limb, Compressible _Cardiovascular · 21 CFR 870.5800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW ## Overview - **Product Code:** JOW - **Device Name:** Sleeve, Limb, Compressible - **Regulation:** [21 CFR 870.5800](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5800) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 350) Showing 20 most recent of 350 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250242](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K250242.md) | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | Apr 24, 2026 | SESE | | [K254267](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K254267.md) | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | Feb 24, 2026 | SESE | | [K250974](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K250974.md) | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | Dec 12, 2025 | SESE | | [K250190](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K250190.md) | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | Dec 8, 2025 | SESE | | [K251466](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K251466.md) | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. | Oct 28, 2025 | SESE | | [K251446](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K251446.md) | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | Sep 17, 2025 | SESE | | [K251086](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K251086.md) | PnueAira (PNCU-01) | Biotab, LLC | Aug 18, 2025 | SESE | | [K250817](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K250817.md) | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | Aug 8, 2025 | SESE | | [K241096](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K241096.md) | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | Jan 15, 2025 | SESE | | [K240499](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K240499.md) | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | Oct 11, 2024 | SESE | | [K241746](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K241746.md) | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF | United Medical Resources, LLC | Oct 4, 2024 | SESE | | [K232640](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K232640.md) | Venowave VW5 | Thermabright | Jun 25, 2024 | SESE | | [K240125](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K240125.md) | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | Jun 21, 2024 | SESE | | [K234155](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K234155.md) | Nimbl (model PD08-N1) | Tactile Medical | Jun 21, 2024 | SESE | | [K232270](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K232270.md) | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | Mar 6, 2024 | SESE | | [K240011](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K240011.md) | Lymphedema Compression | Jkh Health Co., Ltd. | Feb 23, 2024 | SESE | | [K223228](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K223228.md) | Dayspring | Koya Medical, Inc. | Jan 4, 2024 | SESE | | [K232300](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K232300.md) | ElastiMed SACS | Elastimed , Ltd. | Dec 22, 2023 | SESE | | [K231801](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K231801.md) | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | Dec 14, 2023 | SESE | | [K222823](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW/K222823.md) | AeroDVx Arm System | Sun Scientific, Inc. | Sep 7, 2023 | SESE | ## Top Applicants - Bio Compression Systems, Inc. — 11 clearances - Mego Afek AC , Ltd. — 11 clearances - Hygia Health Services, Inc. — 9 clearances - Medical Compression Systems (Dbn) , Ltd. — 9 clearances - Aircast, Inc. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/JOW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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