DEVICE: Aura Wellness (00850026680072)
Device Identifier (DI) Information
Aura Wellness
Nova HD+
In Commercial Distribution
APN-00067
Aura Wellness, LLC
Nova HD+
In Commercial Distribution
APN-00067
Aura Wellness, LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NGX | Stimulator, Muscle, Powered, For Muscle Conditioning |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K220938 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 5 and 30 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 |
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No Device Sizes |
Device Record Status
7d773655-7e8c-41a2-a978-a5aa1f1eed3c
September 14, 2023
1
September 06, 2023
September 14, 2023
1
September 06, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
502-714-1993
support@aurawell.com
support@aurawell.com