Nova HD+— 510(k) K220938

Substantially Equivalent

Aura Wellness, LLC

FDA 510(k) clearance K220938 for Nova HD+, Substantially Equivalent on 2023-08-22. Applicant: Aura Wellness, LLC. Device class: 2.

Clearance details

Applicant: Aura Wellness, LLC
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2022-03-31
Decision date: 2023-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.