inforMED
KYSClass I

Insoles, Medical

General Hospital · 21 CFR 880.6280

MDR events32All time
Recalls0All time
Registered firms125Currently listed
510(k) clearances1All time

Recent MDR events

32 adverse event reports on file

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Event type breakdown

Injury28
Other2
Unspecified1
Malfunction1

Most-reported manufacturers

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Djo Llc18Unspecified3Djo, Llc3Dr Comfort, A Djo, Llc Company3Amfit1Nikken, Inc.1Resa Wearables, Inc.1Therasoles1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

125 firms currently registered for this product code

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510(k) clearances

1 clearances for this product code

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