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510(k) K221058

LungTrainer (MD2 & MD3) by Lung Trainers, LLC — Product Code BWF

K221058 is an FDA 510(k) premarket notification submitted by Lung Trainers, LLC for the device "LungTrainer (MD2 & MD3)". The FDA issued a decision of Substantially Equivalent on July 5, 2023. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2023
Date Received
April 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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FDA data resources