JOW · Sleeve, Limb, Compressible
Cardiovascular · 21 CFR 870.5800 · Class 2
Overview
| Product Code | JOW |
|---|---|
| Device Name | Sleeve, Limb, Compressible |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 349)
Showing 20 most recent of 349 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | Feb 24, 2026 | SESE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | Dec 12, 2025 | SESE |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | Dec 8, 2025 | SESE |
| K251466 | 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 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | Sep 17, 2025 | SESE |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | Aug 18, 2025 | SESE |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | Aug 8, 2025 | SESE |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | Jan 15, 2025 | SESE |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | Oct 11, 2024 | SESE |
| K241746 | 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 | Venowave VW5 | Thermabright | Jun 25, 2024 | SESE |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | Jun 21, 2024 | SESE |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | Jun 21, 2024 | SESE |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | Mar 6, 2024 | SESE |
| K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | Feb 23, 2024 | SESE |
| K223228 | Dayspring | Koya Medical, Inc. | Jan 4, 2024 | SESE |
| K232300 | ElastiMed SACS | Elastimed , Ltd. | Dec 22, 2023 | SESE |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | Dec 14, 2023 | SESE |
| K222823 | AeroDVx Arm System | Sun Scientific, Inc. | Sep 7, 2023 | SESE |
| K232006 | LEGACY® IPC | Ig Technology, Ltd. | Aug 4, 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
