Airos
AIROS 6 Chamber Medium Double Extra Wide Leg Garment (Cool Gray)
24manufacturers in China registered for this device type
101catalogue numbers in this listing
7510(k) clearances naming this product 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 | Airos Medical Inc, United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2024-05-14 |
| Record revised | 2024-09-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -13 to 158 °F |
| Packaging | Case of 10, case of 5, case of 100, case of 20, case of 40 |
| Sizes | Length 18 to 56 in; width 80 cm; balloon length 36 in; length 32 Kilometer |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6-HWL02 | Length 18 in | In distribution |
| ACG01 | In distribution | |
| 8-APR01 | Length 29 in | In distribution |
| A800A | In distribution | |
| APXLR01 | Width 80 cm | In distribution |
| ACG02 | In distribution | |
| 8-MWL02 | Length 32 in | In distribution |
| 8-SWL01 | Length 26 in | In distribution |
| 8-LXWL02 | Length 36 in | In distribution |
| 6-APR02 | In distribution | |
| 8-SP01 | Length 46 in | In distribution |
| 6-SWL02 | Length 26 in | In distribution |
| 8-SPXXL02 | Length 46 in | In distribution |
| 8-LL01 | Length 36 in | In distribution |
| 6-LXWL02 | Length 36 in | In distribution |
| APXLL01 | Width 80 cm | In distribution |
| 8-LP01 | Length 56 in | In distribution |
| 8-SL01 | Length 26 in | In distribution |
| 8-SL02 | Length 29 in | In distribution |
| 8-MWL01 | Length 29 in | In distribution |
| A600A | In distribution | |
| 6-APL02 | In distribution | |
| 6-MWL01 | Length 29 in | In distribution |
| 8-LXWL01 | Length 36 in | In distribution |
| 8-MXWL01 | Length 29 in | In distribution |
| 6-MP02 | Length 50 in | In distribution |
| 8-LP02 | Length 56 in | In distribution |
| 8-MP02 | Length 50 in | In distribution |
| 6-LA02 | Length 32 in | In distribution |
| APXLL02 | Width 80 cm | In distribution |
| A800 | In distribution | |
| AACD03 | In distribution | |
| 6-LWL01 | Length 36 in | In distribution |
| 8-MA02 | Length 29 in | In distribution |
| 8-SXWL02 | In distribution | |
| A600P | In distribution | |
| 8-APLP01 | Length 29 in | In distribution |
| 6-SDXWL01 | Length 26 in | In distribution |
| 8-APL02 | In distribution | |
| 8-MXWL02 | Length 32 in | In distribution |
| 6-APLP01 | Length 29 in | In distribution |
| 6-ML02 | Length 32 in | In distribution |
| 8-SWL02 | Length 29 in | In distribution |
| 6-SL01 | Length 26 in | In distribution |
| 6-HWL01 | Length 18 in | In distribution |
| 6-LXWL01 | Length 36 in | In distribution |
| 8-SP02 | Length 46 in | In distribution |
| 8-APL01 | Length 29 in | In distribution |
| 6-SP02 | Length 46 in | In distribution |
| 8-APRP01 | Length 29 in | In distribution |
| 6-SDXWL02 | Length 26 in | In distribution |
| 6-SWL01 | Length 26 in | In distribution |
| 8-LA01 | Length 32 in | In distribution |
| 6-MA02 | Length 29 in | In distribution |
| 6-SL02 | Length 26 in | In distribution |
| 6-APR01 | Length 29 in | In distribution |
| 6-APL01 | Length 29 in | In distribution |
| 6-LL01 | Length 36 in | In distribution |
| 6-MXWL02 | Length 32 in | In distribution |
| 8-LPXXL02 | Length 56 in | In distribution |
| AACD01 | In distribution | |
| 8-LPXL02 | Length 56 in | In distribution |
| 6-SXWL02 | Length 26 in | In distribution |
| 6-SP01 | Length 46 in | In distribution |
| 8-MP01 | Length 50 in | In distribution |
| 8-SPXL02 | Length 46 in | In distribution |
| 8-SXWL01 | Length 26 in | In distribution |
| 8-LL02 | Length 36 in | In distribution |
| 6-HL01 | Length 18 in | In distribution |
| 8-LWL01 | Length 36 in | In distribution |
| 6-APRP01 | Length 29 in | In distribution |
| 6-MP01 | Length 50 in | In distribution |
| 6-MWL02 | Length 32 in | In distribution |
| 8-ML01 | Length 29 in | In distribution |
| A600 | In distribution | |
| 6-LP01 | Length 56 in | In distribution |
| APXLR02 | Width 80 cm | In distribution |
| A800P | In distribution | |
| 8-MPXL02 | Length 50 in | In distribution |
| 6-LL02 | Balloon Length 36 in | In distribution |
| 6-LWL02 | Length 36 in | In distribution |
| 6-MDXWL02 | Length 32 in | In distribution |
| 8-MDXWL02 | Length 32 in | In distribution |
| 8-MPXXL02 | Length 50 in | In distribution |
| 8-MA01 | Length 29 in | In distribution |
| 6-SXWL01 | Length 26 in | In distribution |
| 6-LP02 | Length 56 in | In distribution |
| A800PA | In distribution | |
| 8-ML02 | Length 32 in | In distribution |
| 8-APR02 | In distribution | |
| 8-LWL02 | Length 36 in | In distribution |
| 8-SDXWL02 | Length 29 in | In distribution |
| 6-HL02 | Length 18 in | In distribution |
| 6-ML01 | Length 32 in | In distribution |
| 6-MA01 | Length 29 in | In distribution |
| 6-LA01 | Length 32 in | In distribution |
| 6-MXWL01 | Length 29 in | In distribution |
| 8-MDXWL01 | Length 32 in | In distribution |
| 6-MDXWL01 | Length 32 in | In distribution |
| 8-SDXWL01 | Length 26 in | In distribution |
| 8-LA02 | Length 32 Kilometer | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240499 | 2024-10-11 |
| K223195 | 2022-12-09 |
| K223193 | 2022-12-09 |
| K193068 | 2019-12-04 |
| K193069 | 2019-12-04 |
| K172779 | 2018-06-22 |
| K172770 | 2018-06-22 |
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.