MedX SLD Light Cluster

The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The…

Registry build 21.09.26

The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The accessory contains a large number of Light emitting diodes that are used to treat a variety of medical conditions such as swelling, inflammation, pain, bruising, wound healing and many other medical conditions. This laser medical device accessory is controlled and powered by MBM 1100N. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.

235manufacturers in China registered for this device type
2catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code ILY
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

Regulatory record for MedX SLD Light Cluster
Listed by MedX Health Corp., Canada
FDA product code ILY
Device type Lamp, Infrared, Therapeutic Heating
Device class Class 2
Regulation 21 CFR 890.5500
Establishment Manufacturer
510(k) K032231
Record published 2016-09-24
Record revised 2022-12-08 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number
Storage Storage environment temperature -4 to 149 °F; Handling environment humidity 20 to 95 % RH; Handling environment temperature 32 to 104 °F
Packaging Shippng carton box of 2

Catalogue Numbers

Catalogue numbers for MedX SLD Light Cluster
Catalogue number Size Status
1001 In distribution
MCT1000 In distribution

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer