AeroWrap™
The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ gradient…
The AeroWrap ™ System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap ™ Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use.
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (19), Guangdong (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Caremax Co., Ltd. | Suzhou, Jiangsu Province | Contract manufacturer | 17 | |
| Viecura Medical Group Limited | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Nanjing HI-Tech Tape Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 8 |
| Qidong Farjoy Medical Material Co., Ltd. | Qidong | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 87. All 87 manufacturers in China registered for Dressing, Compression
Record
| Listed by | SUN-Scientific Inc., United States |
|---|---|
| FDA product code | MHW |
| Device type | Dressing, Compression |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K070457 |
| Record published | 2021-04-30 |
| Record revised | 2022-06-23 (version 2) |
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 |
| Distribution end date | 2030-10-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Medium | In distribution | |
| Extra Large | In distribution | |
| Large, Short | In distribution | |
| Large | In distribution | |
| Small Short | In distribution | |
| Medium Short | In distribution | |
| Small | In distribution | |
| Extra Large, Short | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vive | Vive Health LLC | 77 |
| AeroWrap™ Full Leg | SUN-Scientific Inc. | 63 |
| Aerowrap® Full Leg Tall Flex | SUN-Scientific Inc. | 48 |
| DeRoyal | Deroyal Industries, Inc. | 42 |
| MediChoice | Owens & Minor Distribution, Inc. | 25 |
| SpandaGrip | Medi-Tech, Inc. | 23 |
| CoFlex TLC | Andover Healthcare, Inc. | 17 |
| AeroWrap® Full Leg Tall | SUN-Scientific Inc. | 16 |
| AMD-Ritmed | AMD Medicom Inc. | 12 |
| HCS | Dyad Medical Sourcing, LLC | 12 |
| Medline | Medline Industries, Inc. | 10 |
| OmniTrustTM | Omni Intl., Inc. | 8 |
Showing 12 of 138. All products under Dressing, Compression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070457 | 2007-05-16 |
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.