510(k) clearances

Nova HD+

Aura Wellness, LLC · Physical Medicine

K262788Substantially EquivalentSpecialSGT
Open FDA's page for this record
Third party flag
N
City
Louisville
Advisory committee description
Physical Medicine
Address 1
2208 Plantside Dr.
Statement or summary
Summary
Product code
SGT
Zip code
40299
Applicant
Aura Wellness, LLC
Decision date
2026-08-31
Decision code
SESE
Country code
US
Device name
Nova HD+
Advisory committee
PM
Contact
Scott Blomberg
K number
K262788
State
KY
Date received
2026-08-06
Review advisory committee
PM
Postal code
40299
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Electromagnetic Stimulator For Healthy Muscle Stimulation
Medical specialty description
Physical Medicine
Regulation number
890.5850
Device class
2
Registration number
3018608545
FEI number
3018608545
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.