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Aura Wellness

FDA UDI

Class II (US FDA UDI)

by Aura Wellness, LLC

Identity

Trade Name
Aura Wellness FDA UDI
Generic Name
Deep-tissue electromagnetic stimulation system, home-use FDA UDI
Device Name
The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, the Nova HD+ is easy to operate and incorporates many features to improve or facilitate muscle performance. The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. FDA UDI
Model / Reference
Nova HD+ Starter Kit FDA UDI
Description
The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, the Nova HD+ is easy to operate and incorporates many features to improve or facilitate muscle performance. The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. FDA UDI

Identifiers

Catalog Number
APN-00053 FDA UDI
Primary DI / UDI-DI
00850026680188 FDA UDI
510(k) Number
K220938 FDA UDI
FDA Product Code
NGX FDA UDI
GMDN Term
Deep-tissue electromagnetic stimulation system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Aura Wellness by Aura Wellness, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Deep-tissue electromagnetic stimulation system, home-use.

Cleared under the same submission

K220938 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aura Wellness, LLC

Sources (1)

  • FDA UDI b082194a-b67e-41cd-a49e-7c3c72ba3b40 37 fields · synced May 30, 2026