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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 Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Wave is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation FDA UDI
Model / Reference
Aura Wave FDA UDI
Description
The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits to the patient using magnetic fields. With an array of interchangeable coils, the system can be used to treat a variety of muscles. The Aura Wave is intended to maintain of encourage a general state of health by: - Massage like benefits to aid in personal relaxation - Like Massage, PEMF can provide relief from anxiety and stress - Provides joint and muscle relief due to strenuous sports and work activity - Benefits total wellness and life rejuvenation FDA UDI

Identifiers

Catalog Number
APN-00068 FDA UDI
Primary DI / UDI-DI
00850026680140 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Deep-tissue electromagnetic stimulation system, professionalDeep-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 e9e5e7a0-c3ef-49ed-aa33-03eb317b2a68 34 fields · synced May 30, 2026