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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 Wings PEMF accessory coil is used in conjunction with Aura Wellness line of PEMF therapy devices. FDA UDI
Model / Reference
Wings FDA UDI
Description
The Wings PEMF accessory coil is used in conjunction with Aura Wellness line of PEMF therapy devices. FDA UDI

Identifiers

Catalog Number
aura-wings-2p/6ft FDA UDI
Primary DI / UDI-DI
00850026680034 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

Yes

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 6f934156-bc30-4727-aec5-096d1eb98a21 36 fields · synced May 30, 2026