Espire
55 catalogue numbers from Espire Elbow Pro- Left- Jet Black- Stand, listed by Hugh Steeper Ltd, United Kingdom, under Joint, Elbow, External Limb Component, Powered. 4 manufacturers in China are registered for this product code.
Joint, Elbow, External Limb Component, Powered
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- AID United International Co., Limited Shanghai
- Fortune Company Ltd. Guangdong, contract manufacturer
- Medex Medical Supplies Ltd. Guangdong, contract manufacturer
- Yangzhou Sensport Healthcare Supplies Co., Ltd. Jiangsu
How Is IRE Classified?
Joint, Elbow, External Limb Component, Powered is FDA product code IRE, Class 1, 21 CFR 890.3420.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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