Medline ReNewal
3015-PL @venaflow Calf & Thigh Cuff, W/F
24manufacturers in China registered for this device type
65catalogue numbers in this listing
1510(k) clearance
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Record published | 2016-10-14 |
| Record revised | 2024-11-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 10, case of 5, case of 4, box of 5, case of 3 |
| Sizes | Circumference 12 to 29 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ALP3RR | circumference up to 29 inchces | In distribution | |
| 9530R | 2 | In distribution | |
| ALP1R | 2 | In distribution | |
| DVT60R | 2 | In distribution | |
| MDS630SCR | circumference up to 22 inchces | In distribution | |
| 3012R | Circumference 22 in | In distribution | |
| MDS630MCR | circumference 22 -29 inches | In distribution | |
| VP501MR | 2 | In distribution | |
| 9789R | 2 | In distribution | |
| 5065R | 2 | In distribution | |
| TMREP114050 | circumference up to 13 inches | In distribution | |
| UM3015PLR | Circumference 29 in | In distribution | |
| DVT30R | 2 | In distribution | |
| VP501LR | 2 | In distribution | |
| REP115685 | circumference up to 12 inches | In distribution | |
| 3045R | Circumference 29 in | In distribution | |
| 9780R | 2 | In distribution | |
| TMREP115679 | circumference 18 – 22 inches | In distribution | |
| 3042R | 2 | In distribution | |
| DVT20R | 2 | In distribution | |
| REP115689 | circumference up to 22 inches | In distribution | |
| 5897RR | In distribution | ||
| FG200RR | 2 | In distribution | |
| FG100ER | 2 | In distribution | |
| MDS620LR | 2 | In distribution | |
| 1010330104649 | Circumference 12 in | In distribution | |
| 3016PLR | 2 | In distribution | |
| DVT10R | 2 | In distribution | |
| MDS630LCR | circumference 22 -32 inches | In distribution | |
| 5480R | 2 | In distribution | |
| 5345R | 2 | In distribution | |
| REP115688 | circumference 22 – 32 inches | In distribution | |
| 5329R | 2 | In distribution | |
| REP115687 | circumference 18 – 22 inches | In distribution | |
| L501MR | 2 | In distribution | |
| 3012PLR | Circumference 22 in | In distribution | |
| TMREP114051 | circumference 18 – 22 inches | In distribution | |
| TMREP118263 | circumference up to 12 inchces | In distribution | |
| 9545R | 2 | In distribution | |
| 5107R | 2 | In distribution | |
| ALP2R | 2 | In distribution | |
| REP115683 | circumference 23-45 inches | In distribution | |
| CTREP115686 | circumference 12 – 18 inches | In distribution | |
| UM5898CR | Circumference 29 in | In distribution | |
| 3016R | Circumference 16 in | In distribution | |
| 5489R | 2 | In distribution | |
| ALP1AR | 2 | In distribution | |
| ALP3R | 2 | In distribution | |
| VP520R | 2 | In distribution | |
| 5898LR | In distribution | ||
| REP118213 | circumference 22-29 inches | In distribution | |
| DVT40R | 2 | In distribution | |
| 3015R | Circumference 29 in | In distribution | |
| 3010PLR | 2 | In distribution | |
| MDS630BCR | has circumference of 22-32 inches | In distribution | |
| 3040R | 2 | In distribution | |
| MDS630BDCR | circumference 22 -32 inches | In distribution | |
| TMREP117254 | circumference 22-29 inches | In distribution | |
| UM5897CR | Circumference 29 in | In distribution | |
| 5075R | 2 | In distribution | |
| MDS630LSQR | 2 | In distribution | |
| TMREP115678 | circumference 22 – 32 inches | In distribution | |
| REP118082 | circumference 22-29 inches | In distribution | |
| 3050R | 2 | In distribution | |
| 3046R | 2 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170415 | 2017-09-08 |
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.