Albahealth
Legacy Logix Foot Sleeve Regul
24manufacturers in China registered for this device type
38catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Albahealth, LLC, United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| 510(k) | K123308 |
| Record published | 2019-03-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 10, pack of 24, pack of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BLF700012100304 | In distribution | |
| BLB500002100304 | In distribution | |
| B53558G22100304 | In distribution | |
| BLL500002100304 | In distribution | |
| 053558C22100304 | In distribution | |
| 0LL500032100304 | In distribution | |
| 0LS500022100304 | In distribution | |
| 0LB500032100304 | In distribution | |
| BLS500032100304 | In distribution | |
| B53558G12100304 | In distribution | |
| 0LL500022100304 | In distribution | |
| 0LB500002100304 | In distribution | |
| 0LF700012100304 | In distribution | |
| BLL500012100304 | In distribution | |
| B53558022100304 | In distribution | |
| BLB500012100304 | In distribution | |
| 0LL500002100304 | In distribution | |
| 0LS500012100304 | In distribution | |
| 053558G12100304 | In distribution | |
| 0LS500002100304 | In distribution | |
| 0LB500022100304 | In distribution | |
| 0LB500012100304 | In distribution | |
| BLS500012100304 | In distribution | |
| 0LF700022100304 | In distribution | |
| 053558012100304 | In distribution | |
| 053558G22100304 | In distribution | |
| B53558012100304 | In distribution | |
| 0LX500000000304 | In distribution | |
| 0LL500012100304 | In distribution | |
| BLB500022100304 | In distribution | |
| BLB500032100304 | In distribution | |
| BLS500022100304 | In distribution | |
| BLF700022100304 | In distribution | |
| BLL500032100304 | In distribution | |
| 053558022100304 | In distribution | |
| BLS500002100304 | In distribution | |
| BLL500022100304 | In distribution | |
| 0LS500032100304 | 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 |
|---|---|
| K141609 | 2014-07-15 |
| K123308 | 2013-02-08 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-10-12 | Not classified | Component change control | The wrap portion of the device was tearing at the seam. | 2,582 pairs | 2012-03-30 |
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.