Aura Wellness APN-00067
GUDID 00850026680072
The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, the Nova HD+ is easy to operate and incorporates many features to improve or facilitate muscle performance. The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Aura Wellness, LLC
Deep-tissue electromagnetic stimulation system, home-use| Primary Device ID | 00850026680072 |
| NIH Device Record Key | 7d773655-7e8c-41a2-a978-a5aa1f1eed3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aura Wellness |
| Version Model Number | Nova HD+ |
| Catalog Number | APN-00067 |
| Company DUNS | 101299038 |
| Company Name | Aura Wellness, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 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 93 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850026680072 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220938
FDA Product Code
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.