Therm-X
Therm-X Half-Leg (Lower Leg) Garment (005.00)
24manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
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 | Zenith Technical Innovations, LLC, United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Manufacturer |
| 510(k) | K181149 |
| Record published | 2018-09-17 |
| Record revised | 2019-05-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 33 to 122 °F; Handling environment temperature 33 to 122 °F; Storage environment humidity up to 60 % RH; Handling environment humidity up to 60 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Bag of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Therm-X AT | In distribution | |
| Therm-X Hip Garment | In distribution | |
| Therm-X Ankle Garment | In distribution | |
| Therm-X Pro | In distribution | |
| Therm-X HOME | In distribution | |
| Therm-X Back SPU | In distribution | |
| Therm-X Back Garment | In distribution | |
| Therm-X Shoulder Garment | In distribution | |
| Therm-X HOME | In distribution | |
| Therm-X Ankle SPU | In distribution | |
| Therm-X Split Umbilical Hose | In distribution | |
| Therm-X Extender Straps | In distribution | |
| Therm-X Knee SPU | In distribution | |
| Therm-X Calf DVT Garment | In distribution | |
| Therm-X Knee SPU | In distribution | |
| Therm-X Split Umbilical Hose | In distribution | |
| Therm-X Half-Leg Garment | In distribution | |
| Therm-X Back Garment | In distribution | |
| Therm-X AT | In distribution | |
| Therm-X Back SPU | In distribution | |
| Therm-X Knee Garment | In distribution | |
| Therm-X Elbow Garment | In distribution | |
| Therm-X AT | In distribution | |
| Therm-X Ankle Garment | In distribution | |
| Therm-X Half-Leg Garment | In distribution | |
| Therm-X Disposable Calf DVT Garment | In distribution | |
| Therm-X Power Supply and Cord (Medical Grade) | In distribution | |
| Therm-X Extender Straps | In distribution | |
| Therm-X Hand Garment | In distribution | |
| Therm-X Ankle SPU | In distribution | |
| Therm-X Shoulder Garment | In distribution | |
| Therm-X Hip SPU | In distribution | |
| Therm-X Knee Garment | In distribution | |
| Therm-X HOME | In distribution | |
| Therm-X Hip SPU | In distribution | |
| Therm-X Hand Garment | In distribution | |
| Therm-X Umbilical Hose | In distribution | |
| Therm-X Foot DVT Garment | In distribution | |
| Therm-X Elbow Garment | In distribution | |
| Therm-X Hip Garment | 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 |
| Airos | Airos Medical Inc | 101 |
| 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 |
Showing 12 of 363. All products under Sleeve, Limb, Compressible
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240125 | 2024-06-21 |
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.