Bio Arterial Deluxe
Bio Arterial Deluxe is a prescription pneumatic compression system intended to improve circulation in the upper and lower limbs. It also serves as adjunct therapy for ischemic disease of…
Bio Arterial Deluxe is a prescription pneumatic compression system intended to improve circulation in the upper and lower limbs. It also serves as adjunct therapy for ischemic disease of the lower extremities. The system combines an air pump with a compression garment.
The pump inflates garment chambers sequentially from the limb end toward the trunk. A motor-driven disc valve controls airflow from the compressor. Soft keys and an LED display provide control, with adjustable pressure from 20 to 150 mmHg and a cycle of five seconds compression followed by fifteen seconds release.
Treatment Restrictions
Contraindications include fragile skin or open or freshly healed wounds in the treated region, untreated limb infection, suspected or confirmed deep-vein thrombosis, inflammatory phlebitis or pulmonary embolism, uncontrolled congestive heart failure, undesirable venous or lymphatic return, limb sepsis, recent skin grafts, pulmonary edema and acute thrombophlebitis.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (7), Zhejiang (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 13 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Caremate Medical Device Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 6 |
| Dongguan Esino Manufacturing Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| MedHealth Medical Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
Showing 12 of 24. All 24 manufacturers in China registered for Sleeve, Limb, Compressible
Record
| Listed by | BIO Compression Systems, Inc., United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Manufacturer |
| 510(k) | K250974 |
| Record published | 2026-02-13 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IC-BAP-DX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flexitouch Plus | Tactile Systems Technology Inc | 151 |
| Flexitouch | Tactile Systems Technology Inc | 138 |
| Sleeve, Limb, Compressible | Stryker Sustainability Solutions | 113 |
| Airos | Airos Medical Inc | 101 |
| Medline | Medline Industries, Inc. | 97 |
| Kendall SCD | Cardinal Health | 73 |
| Wright | Wright Therapy Products, Inc. | 72 |
| ACTitouch | Tactile Systems Technology Inc | 70 |
| Medline ReNewal | Medline Industries, Inc. | 65 |
| Koya Medical | Koya Medical, Inc. | 61 |
| Aircast | DJO, LLC | 60 |
| Hydroven | Huntleigh Healthcare Ltd. | 49 |
Showing 12 of 363. All products under Sleeve, Limb, Compressible
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250974 | 2025-12-12 |
| K210417 | 2021-05-14 |
| K180248 | 2018-08-07 |
| K171793 | 2017-08-17 |
| K150953 | 2015-07-16 |
| K142640 | 2014-11-06 |
| K131306 | 2013-07-22 |
| K131327 | 2013-07-18 |
| K072666 | 2007-11-05 |
| K061857 | 2006-08-01 |
| K043423 | 2005-02-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.