inforMED
PUHClass II

Analyzer, Body Composition, Exempt

Cardiovascular · 21 CFR 870.2770

This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

MDR events3All time
Recalls0All time
Registered firms86Currently listed
510(k) clearances0All time

Recent MDR events

3 adverse event reports on file

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Event type breakdown

Injury3

Most-reported manufacturers

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Fitbit, Inc.2Qardio Inc.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

86 firms currently registered for this product code

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510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.