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Aura Wellness Nova HD+ Starter Kit

by Aura Wellness, LLC

Aura Wellness Nova HD+ Starter Kit (APN-00053) is a deep-tissue electromagnetic stimulation system (FDA Class II) made by Aura Wellness, LLC, cleared under FDA 510(k) K220938 on 22 Aug 2023 and listed in FDA GUDID since 6 Sep 2023 (UDI-DI 00850026680188), active as of 2 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 2 Nov 2026

Documents

510(k) K220938

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850026680188 UDI-DI Date6 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220938 Date22 Aug 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220938 decided 22 Aug 2023 Active
  • FDA GUDID UDI-DI 00850026680188 listed 6 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220938
  2. Listed FDA GUDID 00850026680188

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aura Wellness
Generic name
Deep-tissue electromagnetic stimulation system, professional
Model / Ref / Catalog
Nova HD+ Starter Kit, APN-00053
Primary DI / UDI-DI
00850026680188
FDA product code
NGX, SGT
GMDN term
Deep-tissue electromagnetic stimulation system, professional
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Deep-tissue electromagnetic stimulation system, home-use

Cleared under the same submission (K220938)

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Aura Wellness, LLC

See all devices from Aura Wellness, LLC →

Properties

  • Over-the-counter
  • Convenience kit
  • Manufacturing date
Other properties (12, all answered No)