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510(k) K211941

9Line by Energetic Designs, Inc. — Product Code DSA

K211941 is an FDA 510(k) premarket notification submitted by Energetic Designs, Inc. for the device "9Line". The FDA issued a decision of Substantially Equivalent on January 27, 2022. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
June 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

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FDA data resources