ActiveCare
15 catalogue numbers from ActiveCare DVT, listed by Medical Compression System (D.B.N.) Ltd., under Sleeve, Limb, Compressible. 24 manufacturers in China are registered for this product code.
24manufacturers in China registered for this device type
15catalogue numbers in this listing
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 | Medical Compression System (D.B.N.) Ltd. |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| 510(k) | K140755 |
| Record published | 2017-08-04 |
| Record revised | 2024-09-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 14 to 86 °F; Storage environment humidity 10 to 85 % RH |
| Packaging | Pack of 10, pack of 2, pack of 12, pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ActiveCare DVT | In distribution | |
| ActiveCare Foot sleeve Pair | In distribution | |
| ActiveCare calf sleeve Medium pair | In distribution | |
| ActiveCare calf sleeve+stock Large pair | In distribution | |
| ActiveCare+S.F.T | In distribution | |
| ActiveCare Thigh sleeve small Pair | In distribution | |
| ActiveCare calf sleeve X-Large pair | In distribution | |
| ActiveCare calf sleeve Small Pair | In distribution | |
| HomeCare ActiveCare+S.F.T | In distribution | |
| ActiveCare Thigh sleeve Medium Pair | In distribution | |
| ActiveCare calf sleeve+stock X-Large pair | In distribution | |
| ActiveCare calf sleeve+stock Small Pair | In distribution | |
| ActiveCare Thigh sleeve Large Pair | In distribution | |
| ActiveCare calf sleeve Large pair | In distribution | |
| ActiveCare calf sleeve+stock Medium pair | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medical Compression Systems | 510(k) number | 2011-08-28 | Not classified | Device Design | This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare+S.F.T | 551 units | 2012-07-11 |
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.