Class Class I

Zhenjiang Assure Mechanical Wheelchair,model:K1 (K231320)

K231320 2023-06-05 Special
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Description

Zhenjiang Assure Mechanical Wheelchair,model:K1 by Zhenjiang Assure Medical Equipment Co., Ltd., an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK231320
Clearance Date2023-06-05
Clearance TypeSpecial
Product CodeIOR
Regulation Number890.3850

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Predicate lineage for K231320

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Zhenjiang Assure Mechanical Wheelchair,model:K1 (K231320) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRZhenjiang Assure Medical Equipment ...2012

Trace the full predicate network for K231320

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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