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Aura Wellness

FDA UDI

Class I (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 Electronic 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 Aura is easy to operate and incorporates many features to promote human health and well-being. The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body. The Nova HD is intended to be operated and used by the same person. The Nova HD produces non ionizing pulsed electromagnetic field at the applicator. FDA UDI
Model / Reference
Nova HD Starter Kit FDA UDI
Description
The Nova HD Pulsed Electronic 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 Aura is easy to operate and incorporates many features to promote human health and well-being. The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body. The Nova HD is intended to be operated and used by the same person. The Nova HD produces non ionizing pulsed electromagnetic field at the applicator. FDA UDI

Identifiers

Catalog Number
APN-00026 FDA UDI
Primary DI / UDI-DI
00850026680065 FDA UDI
FDA Product Code
ISA FDA UDI
GMDN Term
Deep-tissue electromagnetic stimulation system, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5660 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

Yes

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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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 84b0ce46-bab2-4af4-9dd5-94adcba87cc1 36 fields · synced May 31, 2026