Aura Wellness

Primary DI
00850026680140
Brand
Aura Wellness
Company
Aura Wellness, LLC
Model
Aura Wave
Catalog number
APN-00068
Device description
The Aura Wave 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 Wave 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
Published
2023-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00850026680140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026680140008500266801408500266801400850026680140

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101299038
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026680003Aura WellnessNova HDNOVA HD2022-12-13
00850026680065Aura WellnessNova HD Starter KitAPN-000262022-12-13
00850026680096Aura WellnessAura PulseAPN-000622023-10-13
00850026680102Aura WellnessAura Pulse Starter KitAPN-000502023-10-13
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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