Aura Wellness APN-00091
GUDID 00850026680157
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 | 00850026680157 |
| NIH Device Record Key | 25deadb7-0c99-4d00-8092-c3df2f1ede39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aura Wellness |
| Version Model Number | Aura Wave Starter Kit |
| Catalog Number | APN-00091 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com | |
| Phone | 502-714-1993 |
| support@aurawell.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850026680157 [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 |
Trademark Results [Aura Wellness]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AURA WELLNESS 90226034 not registered Live/Pending |
Aura Wellness, LLC 2020-09-30 |
 AURA WELLNESS 88364692 not registered Live/Pending |
Deondre J Williams 2019-03-31 |
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