FDA UDI
In Commercial Distribution
🇺🇸 United States
Aura Wellness
DI: 00850026680072
·
Model: Nova HD+
·
Aura Wellness, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aura Wellness
- Primary DI
- 00850026680072
- Version / Model
- Nova HD+
- Catalog Number
- APN-00067
- Company Name
- Aura Wellness, LLC
- Labeler DUNS
- 101299038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-06
- Public Version
- 1
- Public Version Date
- 2023-09-14
- Public Version Status
- New
- Public Device Record Key
- 7d773655-7e8c-41a2-a978-a5aa1f1eed3c
Device Description
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
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 | 00850026680072 | GS1 |
Customer Contacts
- Phone
- 502-714-1993
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220938 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- 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