Pressure Therapy System
The PT1002 Pressure Therapy System applies sequential pneumatic compression to the legs. It is indicated for lymphedema, venous insufficiency and edema following trauma, sports injuries or…
The PT1002 Pressure Therapy System applies sequential pneumatic compression to the legs. It is indicated for lymphedema, venous insufficiency and edema following trauma, sports injuries or immobilization. It is intended for medical professionals and for patients at home under medical supervision.
An air pump connects through hoses to dedicated leg sleeves, each containing four compression chambers. The chambers inflate in sequence from the limb end toward the body and then deflate as one cycle. A sensor and microprocessor control airflow timing and pressure.
Listed Item
Indications for Use: The device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymph edema, edema following trauma and sport injures, Post immobilization edema, Venous insufficiencies, Lymph edema. Device Description: The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.
Compression Settings
The system offers two modes, adjustable pressure from 0 to 250 mmHg and a 30-second compression cycle. Session-time selections are 10, 20 or 30 minutes. Small and large leg cuffs are available, and the sleeves use thermoplastic urethane material.
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 | Xiamen Senyang Co., Ltd., China |
|---|---|
| FDA product code | IRP |
| Device type | Massager, Powered Inflatable Tube |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5650 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K161907 |
| Record published | 2026-01-09 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment atmospheric pressure 80 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 5 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PT1002 | 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 |
| SP-1000 | Daesung Maref Co., Ltd. | 19 |
| Homedics | FKA Distributing Co., LLC | 18 |
Showing 12 of 230. All products under Massager, Powered Inflatable Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192358 | 2020-04-23 |
| K181409 | 2019-02-19 |
| K161907 | 2017-02-23 |
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.