Koya Medical
Dayspring Wearable Device - Medium Arm Garment, X-Large Arm Liner, X- Large Gauntlet, Dayspring Controller, and Dayspring Charger
24manufacturers in China registered for this device type
61catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Koya Medical, Inc., United States |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-15 |
| Record revised | 2022-05-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F-0100-24 | In distribution | |
| F-0100-34 | In distribution | |
| F-0100-18 | In distribution | |
| F-0100-17 | In distribution | |
| F-0100-08 | In distribution | |
| F-0100-06 | In distribution | |
| F-0100-01 | In distribution | |
| F-0100-31 | In distribution | |
| F-0010-02 | In distribution | |
| F-0030-01 | In distribution | |
| F-0100-30 | In distribution | |
| F-0100-25 | In distribution | |
| F-0100-38 | In distribution | |
| F-0100-12 | In distribution | |
| F-0100-22 | In distribution | |
| F-0100-32 | In distribution | |
| F-0100-14 | In distribution | |
| F-0100-42 | In distribution | |
| F-0100-39 | In distribution | |
| F-0030-03 | In distribution | |
| F-0100-45 | In distribution | |
| F-0100-36 | In distribution | |
| F-0100-27 | In distribution | |
| F-0100-11 | In distribution | |
| F-0100-04 | In distribution | |
| F-0020-02 | In distribution | |
| F-0100-16 | In distribution | |
| F-0100-09 | In distribution | |
| F-0100-47 | In distribution | |
| F-0100-05 | In distribution | |
| F-0100-07 | In distribution | |
| F-0100-37 | In distribution | |
| F-0100-40 | In distribution | |
| F-0100-28 | In distribution | |
| F-0100-02 | In distribution | |
| F-0020-01 | In distribution | |
| F-0100-26 | In distribution | |
| F-0006-01 | In distribution | |
| F-0100-46 | In distribution | |
| F-0020-04 | In distribution | |
| F-0010-01 | In distribution | |
| F-0100-33 | In distribution | |
| F-0100-21 | In distribution | |
| F-0100-20 | In distribution | |
| F-0100-47 | In distribution | |
| F-0100-13 | In distribution | |
| F-0100-10 | In distribution | |
| F-0100-15 | In distribution | |
| F-0100-29 | In distribution | |
| F-0030-02 | In distribution | |
| F-0100-03 | In distribution | |
| F-0100-35 | In distribution | |
| F-0100-41 | In distribution | |
| F-0030-04 | In distribution | |
| F-0100-43 | In distribution | |
| F-0020-02 | In distribution | |
| F-0100-23 | In distribution | |
| F-0100-19 | In distribution | |
| F-0010-03 | In distribution | |
| F-0100-44 | In distribution | |
| F-0002-01 | 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 |
| Aircast | DJO, LLC | 60 |
| Hydroven | Huntleigh Healthcare Ltd. | 49 |
| Kendall SCD | Cardinal Health 200, LLC | 46 |
Showing 12 of 363. All products under Sleeve, Limb, Compressible
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223228 | 2024-01-04 |
| K212287 | 2021-09-21 |
| K210885 | 2021-04-23 |
| K193288 | 2020-06-16 |
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.