Aura Wellness APN-00068

GUDID 00850026680140

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

Aura Wellness, LLC

Deep-tissue electromagnetic stimulation system, home-use

• Primary Device ID: 00850026680140
• NIH Device Record Key: e9e5e7a0-c3ef-49ed-aa33-03eb317b2a68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aura Wellness
• Version Model Number: Aura Wave
• Catalog Number: APN-00068
• Company DUNS: 101299038
• Company Name: Aura Wellness, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850026680140 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [Aura Wellness]

• 00850026680188: The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specific
• 00850026680157: The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits
• 00850026680140: The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits
• 00850026680072: The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specific
• 00850026680102: The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits
• 00850026680096: The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits