SP-1000
The SP-1000 is a pneumatic compression massager for temporary relief of minor muscle aches and pains and temporary improvement of circulation in people in good health. A pump sends air into…
The SP-1000 is a pneumatic compression massager for temporary relief of minor muscle aches and pains and temporary improvement of circulation in people in good health. A pump sends air into a wearable sleeve with four chambers, inflating them in sequence.
A pressure control adjusts all four chambers together. Repeated inflation and deflation applies compression to the area covered by the sleeve; the center body set includes the controller, sleeve, extension zippers and connecting hose.
Listed Item
Main device 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 2ea, Double Hose 1ea [One set box]
Treatment Controls
A timer controls how long the pump operates and stops it when the selected interval ends. The system supports sessions up to 30 minutes and can be used in professional healthcare or home environments.
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) | K202395 |
| Record published | 2021-12-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Packaging | Box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP10200-BZ | In distribution | |
| SP10200-BX | In distribution | |
| SP10200-AS | In distribution | |
| SP10100-RL | In distribution | |
| SP10100-RX | In distribution | |
| SP10200-BL | In distribution | |
| SP10200-CB | In distribution | |
| SP10200-BX-2 | In distribution | |
| SP10200 | In distribution | |
| SP10100-LX | In distribution | |
| SP10200-BL-2 | In distribution | |
| SP10100-LZ | In distribution | |
| SP10100 | In distribution | |
| SP10100-RZ | In distribution | |
| SP10200-AZ | In distribution | |
| SP10200-AX | In distribution | |
| SP10100-LL | In distribution | |
| SP10200-AL | In distribution | |
| SP10200-BZ-2 | In distribution |
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 |
| Compressible Limb Therapy System(LX7(V7)) | Daesung Maref Co., Ltd. | 30 |
| 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 |
| 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.