Aura Wellness

Primary DI
00850026680003
Brand
Aura Wellness
Company
Aura Wellness, LLC
Model
Nova HD
Catalog number
NOVA HD
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.
Published
2022-12-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026680003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026680003008500266800038500266800030850026680003

GMDN Terms#

Term, Definition table
TermDefinition
Deep-tissue electromagnetic stimulation system, home-useAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure525 Millimeter of Mercury795 Millimeter of Mercury
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure525 Millimeter of Mercury795 Millimeter of Mercury
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-714-1993support@aurawell.com

Regulatory Flags#

DUNS number
101299038
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026680065Aura WellnessNova HD Starter KitAPN-000262022-12-13
00850026680096Aura WellnessAura PulseAPN-000622023-10-13
00850026680102Aura WellnessAura Pulse Starter KitAPN-000502023-10-13
00850026680140Aura WellnessAura WaveAPN-000682023-09-06
00850026680157Aura WellnessAura Wave Starter KitAPN-000912023-09-06
00850026680072Aura WellnessNova HD+APN-000672023-09-06
00850026680188Aura WellnessNova HD+ Starter KitAPN-000532023-09-06
00850026680010Aura WellnessButterfly Loopaura-btf-2p/6ft2022-12-13
00850026680027Aura WellnessLarge Loopaura-lgl-2p/6ft2022-12-13
00850026680034Aura WellnessWingsaura-wings-2p/6ft2022-12-13
00850026680041Aura WellnessHalf Body Mataura-mat-2p/6ft2022-12-13

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