Icon

Icon Knee Charging Blade Kit, Global

Registry build 21.09.26
7manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ISY
Manufacturer City Province Registered as Device types
Dongguan Supercare Medical Products Co., Ltd. Dongguan Guangdong Contract manufacturer 41
Zhejiang Qiangnao Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 2
Yangzhou Sensport Healthcare Supplies Co., Ltd. Yangzhou Jiangsu Manufacturer 27
Orthotech Rehabilitation Co., Ltd. Xiamen Fujian Manufacturer 26
Huae Trade Technology Co., Ltd. Beijing Beijing Contract manufacturer 10
Baoji Shengtaike Industry & Trade Co., Ltd. Baoji Shanxi Contract manufacturer 7
Dongguan Chuangguo Daily Products Co., Ltd. Dongguan Guangdong Manufacturer 4

Record

Regulatory record for Icon
Listed by College Park Industries, United States
FDA product code ISY
Device type Joint, Knee, External Limb Component
Device class Class 1
Regulation 21 CFR 890.3420
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-06-19

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Icon
Catalogue number Size Status
IC CHG AU In distribution
IC CB US In distribution
IC CB AU In distribution
IC CB EU In distribution
IC KPK In distribution
IC CB UK In distribution
IC CHG UK In distribution
LPTC T In distribution
IC CHG EU In distribution
IC CB G In distribution
IC CHG US In distribution
IC MPKA 1000 In distribution
IC BATT In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Capital College Park Industries 19
Tehlin TEH LIN Prosthetic & Orthopaedic, Inc. 19
Rheo Knee Ossur Americas 15
Spark Brownmed 6
Slide.fit Streifeneder ortho.production gmbH 6
Trulife Trulife, Inc. 6
Power Knee Ossur Americas 5
Guardian College Park Industries 5
Imak Compression Brownmed 5
Donjoy Performance DJO, LLC 4
Victor College Park Industries 3
Aura Plus College Park Industries 2

Showing 12 of 24. All products under Joint, Knee, External Limb Component

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