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510(k) K250860

BreatheBand® (Model 1000) by Exemplar Medical, LLC — Product Code BYI

K250860 is an FDA 510(k) premarket notification submitted by Exemplar Medical, LLC for the device "BreatheBand® (Model 1000)". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2025
Date Received
March 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

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FDA data resources