Sleeve, Limb, Compressible
Compression Sleeve Alternating Leg Pressure Thigh
24manufacturers in China registered for this device type
113catalogue numbers in this listing
3recalls on this code
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 | Stryker Sustainability Solutions, United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| 510(k) | K100909 |
| Record published | 2016-09-23 |
| Record revised | 2025-03-26 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -15 to 50 °C |
| Packaging | Case of 10, case of 5, case of 20, pack of 10, case of 3, case of 50 |
| Sizes | Circumference 12 to 36 in; length 6 to 12 ft |
| Distribution end date | 2025-03-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 26.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 36.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 17.375 in | In distribution |
| N/A | Circumference 36.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 19.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 29.0 in | In distribution |
| N/A | In distribution | |
| N/A | Circumference 25.5 in | In distribution |
| N/A | In distribution | |
| N/A | Circumference 21.0 in | In distribution |
| N/A | Circumference 18.0 in | In distribution |
| N/A | Circumference 22.0 in | In distribution |
| N/A | In distribution | |
| N/A | Circumference 21.5 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 21.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 28.0 in | In distribution |
| N/A | In distribution | |
| N/A | Circumference 14.0 in | In distribution |
| N/A | Circumference 22.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 36.0 in | In distribution |
| N/A | Circumference 29.0 in | In distribution |
| N/A | Circumference 16.0 in | In distribution |
| N/A | Circumference 24.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 24.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 29.0 in | In distribution |
| N/A | Circumference 16.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| n/a | In distribution | |
| N/A | Circumference 12.0 in | In distribution |
| N/A | In distribution | |
| N/A | Circumference 36.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 22.0 in | In distribution |
| N/A | In distribution | |
| N/A | Circumference 28.0 in | In distribution |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | In distribution | |
| N/A | Circumference 12.0 in | In distribution |
| N/A | Circumference 14.0 in | In distribution |
| N/A | In distribution | |
| N/A | Length 12.0 ft | Withdrawn |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Circumference 14.5 in | Withdrawn |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Length 10.5 ft | Withdrawn |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Length 6.0 ft | Withdrawn |
| N/A | Circumference 26.0 in | Withdrawn |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Circumference 26.0 in | Withdrawn |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Withdrawn | |
| N/A | Circumference 26.0 in | Withdrawn |
| N/A | Circumference 20.0 in | Withdrawn |
| N/A | Length 12.0 ft | Withdrawn |
| N/A | Circumference 14.0 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flexitouch Plus | Tactile Systems Technology Inc | 151 |
| Flexitouch | Tactile Systems Technology Inc | 138 |
| 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 |
| Kendall SCD | Cardinal Health 200, LLC | 46 |
Showing 12 of 363. All products under Sleeve, Limb, Compressible
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Sustainability Solutions | 510(k) number | 2023-04-14 | Class II | Under Investigation by firm | Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged. | 50 units | |
| Stryker Sustainability Solutions | UDI-DI | 2017-12-01 | Class II | Packaging | 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. | 280 devices | 2018-09-27 |
| Stryker Sustainability Solutions | 510(k) number | 2012-08-30 | Class II | Process control | Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. | 1,311 | 2014-09-30 |
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.