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Manufacturers
US
Aura Wellness, LLC
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Medical Device Manufacturer
·
US , Louisville , KY
Aura Wellness, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
Recent clearances:
Aura Wave
,
Nova HD+
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Aura Wellness, LLC
Physical Medicine
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 02, 2025
Aura Wave
K250896
·
SGT
Physical Medicine
·
252d
Cleared
Aug 22, 2023
Nova HD+
K220938
·
NGX
Physical Medicine
·
509d
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Physical Medicine
2