Class Class II

Aura Wave (K250896)

K250896 2025-12-02 Traditional
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Description

Aura Wave by Aura Wellness, LLC, an FDA 510(k) cleared physical medicine device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250896
Clearance Date2025-12-02
Clearance TypeTraditional
Product CodeSGT
Regulation Number890.5850

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