Compressible Limb Therapy System(LX7(V7))
4Chamber one-touch center-body sleeve (one size) with 2 extension zipper
37manufacturers in China registered for this device type
30catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (17), Fujian (10), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shenzhen Yicai Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Zhangzhou Easepal Innovation Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 7 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Youwen Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Ryder Electronics (Xinfeng) Ltd. | Ganzhou | Jiangxi | Contract manufacturer | 1 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Fofo Medical Co., Ltd. | Xiamen | Fujian | Exporter | 18 |
| Shenzhen Ruiyi Business Technology Co., Ltd. | Shenzhen | Guangdong | Specification developer | 13 |
Showing 12 of 37. All 37 manufacturers in China registered for Massager, Powered Inflatable Tube
Record
| Listed by | Daesung Maref Co., Ltd., South Korea |
|---|---|
| FDA product code | IRP |
| Device type | Massager, Powered Inflatable Tube |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K102320 |
| Record published | 2017-12-11 |
| Record revised | 2018-07-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 20, box of 10, box of 6, box of 40 |
| Distribution end date | 2017-12-11 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ACg0431 | 2 | In distribution | |
| ACg0461 | In distribution | ||
| ACg0413 | In distribution | ||
| ACg0412 | In distribution | ||
| ACg0463 | In distribution | ||
| ACg0430 | 2 | In distribution | |
| ACg0465 | In distribution | ||
| ACg0410-1 | In distribution | ||
| ACg0468 | In distribution | ||
| ACg0410 | In distribution | ||
| ACg0410-3 | In distribution | ||
| ACg0462 | In distribution | ||
| ACg0410-2 | In distribution | ||
| ACg0467 | In distribution | ||
| ACg0481 | In distribution | ||
| ACg0469 | In distribution | ||
| ACg0411 | In distribution | ||
| ACg0466 | In distribution | ||
| ACg0460 | In distribution | ||
| ACg0433 | 2 | In distribution | |
| ACg0430-1 | 2 | In distribution | |
| ACg0464 | In distribution | ||
| ACg0480 | In distribution | ||
| ACg0413 | In distribution | ||
| ACg0413 | Withdrawn | ||
| ACg0433 | 2 | Withdrawn | |
| ACg0480 | Withdrawn | ||
| ACg0481 | Withdrawn | ||
| ACg0480 | Withdrawn | ||
| ACg0481 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LF900 | Daesung Maref Co., Ltd. | 69 |
| LX9max | Daesung Maref Co., Ltd. | 47 |
| Game Ready | Avanos Medical, Inc. | 34 |
| VU | Xiamen Weiyou Intelligent Technology Co., Ltd. | 28 |
| NormaTec | Normatec Industries, LP | 27 |
| SP-2000 | Daesung Maref Co., Ltd. | 23 |
| BioTab | Vive Health LLC | 23 |
| Rapid Reboot | Rapid Reboot Recovery Products | 22 |
| 4 chamber sleeve | Daesung Maref Co., Ltd. | 21 |
| SP-1000 | Daesung Maref Co., Ltd. | 19 |
| Homedics | FKA Distributing Co., LLC | 18 |
| CoreTech | Vive Health LLC | 17 |
Showing 12 of 230. All products under Massager, Powered Inflatable Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231437 | 2023-07-19 |
| K202395 | 2021-09-01 |
| K203498 | 2021-07-02 |
| K203019 | 2021-06-22 |
| K160178 | 2017-01-11 |
| K150033 | 2015-04-20 |
| K112441 | 2012-01-17 |
| K102320 | 2011-03-04 |
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.