Aura Wellness
Basic Information
- Brand Name
- Aura Wellness
- Primary DI
- 00850026680065
- Version / Model
- Nova HD Starter Kit
- Catalog Number
- APN-00026
- Company Name
- Aura Wellness, LLC
- Labeler DUNS
- 101299038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-13
- Public Version
- 1
- Public Version Date
- 2022-12-21
- Public Version Status
- New
- Public Device Record Key
- 84b0ce46-bab2-4af4-9dd5-94adcba87cc1
Device Description
The Nova HD Pulsed Electronic 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 Aura is easy to operate and incorporates many features to promote human health and well-being. The Nova HD is ideal for all strenuous sports and physical labor recovery as well as for any nuisance aches and pains which may be affecting the users total health and wellness. The Nova HD is a total body wellness device. We also provide many coil attachments designed for use with the Nova HD on various parts of the body. The Nova HD is intended to be operated and used by the same person. The Nova HD produces non ionizing pulsed electromagnetic field at the applicator.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850026680065 | GS1 |
Customer Contacts
- Phone
- 502-714-1993
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity