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Nova HD+

by Aura Wellness, LLC 2 variants

510(k) K262788

Nova HD+ is a medical device (FDA Class II; FDA product code SGT, Electromagnetic Stimulator For Healthy Muscle Stimulation) made by Aura Wellness, LLC, cleared under FDA 510(k) K262788 on 31 Aug 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK262788 Date31 Aug 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
SGT
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

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