DEVICE: Aura Wellness (00850026680072)

Device Identifier (DI) Information

Aura Wellness
Nova HD+
In Commercial Distribution
APN-00067
Aura Wellness, LLC
00850026680072
GS1

1
101299038 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K220938 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7d773655-7e8c-41a2-a978-a5aa1f1eed3c
September 14, 2023
1
September 06, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
502-714-1993
support@aurawell.com
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