AccessGUDID - DEVICE: Aura Wellness (00850026680034)

GUDID

Device Identifier (DI) Information

Brand Name: Aura Wellness
Version or Model: Wings
Commercial Distribution Status: In Commercial Distribution
Catalog Number: aura-wings-2p/6ft
Company Name: Aura Wellness, LLC

Primary DI Number: 00850026680034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101299038 *Terms of Use

Device Description: The Wings PEMF accessory coil is used in conjunction with Aura Wellness line of PEMF therapy devices.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58761	Deep-tissue electromagnetic stimulation system, home-use	An assembly of devices designed to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. It includes an electrically-powered control unit, application pads/flat coils intended to emit EM radiation to the treatment site (e.g., joint), and carrying case for portability. It is not intended to apply an electric current directly to the body. The system is intended to be used in clinical and home settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 525 and 795 Millimeter of Mercury
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f934156-bc30-4727-aec5-096d1eb98a21
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022