FDA.reportPublic FDA data

Aura Wellness

Primary DI
00850026680010
Brand
Aura Wellness
Company
Aura Wellness, LLC
Model
Butterfly Loop
Catalog number
aura-btf-2p/6ft
Device description
The Butterfly Loop PEMF accessory coil is used in conjunction with Aura Wellness line of PEMF therapy devices.
Published
2022-12-13
Public version status
New
Distribution status
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
00850026680010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026680010008500266800108500266800100850026680010

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 Celsius40 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

Contacts#

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

Regulatory Flags#

DUNS number
101299038
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
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
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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Primary DI, Brand, Company table
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