DEVICE: Aura Wellness (00850026680096)
Device Identifier (DI) Information
Aura Wellness
Aura Pulse
In Commercial Distribution
APN-00062
Aura Wellness, LLC
Aura Pulse
In Commercial Distribution
APN-00062
Aura Wellness, LLC
The Aura Pulse 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 Pulse 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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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58762 | Deep-tissue electromagnetic stimulation system, professional |
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); 3) help facilitate soft and hard tissue wound/injury healing; and/or 4) reduce subcutaneous fat layers by muscle stimulation. It includes an electrically-powered control unit and application pads/flat coils intended to emit EM radiation to the treatment site. It is not intended to apply an electric current directly to the body nor produce therapeutic deep heat. The system is intended to be used in a clinical setting only.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ISA | Massager, Therapeutic, Electric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
363778a3-1b46-4772-9a4e-750f0f910d05
October 23, 2023
1
October 13, 2023
October 23, 2023
1
October 13, 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined