Lumiwave
Lumiwave Single LED, 200 LED's, 1x4 Pods
235manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (145), Zhejiang (21), Jiangsu (9). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Dongguan Tutamen Metalwork Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 12 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Wellbeing Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Wuxi Jiajian Medical Instrument Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
| Shenzhen Sungpo HI-Tech Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Shenzhen Allbeauty Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
Showing 12 of 235. All 235 manufacturers in China registered for Lamp, Infrared, Therapeutic Heating
Record
| Listed by | Biocare Systems, Inc., United States |
|---|---|
| FDA product code | ILY |
| Device type | Lamp, Infrared, Therapeutic Heating |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5500 |
| Premarket notification | Exempt |
| Record published | 2016-11-07 |
| Record revised | 2025-04-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLW1X4 | In distribution | |
| DLW2X4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lescolton | Shenzhen Lescolton Medical Equipment Co., Ltd. | 50 |
| HealthLight | Healthlight LLC | 40 |
| Therapy Light | E.shine Lighting Co., Limited | 32 |
| Phoenix Thera-Lase system | Phoenix Thera-Lase Systems, LLC | 32 |
| AisQueen | Shenzhen AIS Queen Medical Technology Co., Ltd. | 30 |
| LED RED Light Therapy Panel | Shenzhen RedV Medical Equipment Co., Ltd. | 27 |
| Chattanooga | DJO, LLC | 25 |
| Lumix Ultra/Plus | Fisioline SRL | 22 |
| UTK | UTK Technology(Shenzhen)Limited | 21 |
| LZ30 | Avant Wellness Systems Inc | 21 |
| LS Pro Systems | Wellness Without Limits LLC | 21 |
| Dimed | Wuhan Dimed Laser Technology Co., Ltd. | 20 |
Showing 12 of 536. All products under Lamp, Infrared, Therapeutic Heating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051816 | 2005-08-26 |
| K042532 | 2004-12-13 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-06-14 | Not classified | Other | Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard | 175 units | 2011-01-03 |
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.