FDA.reportPublic FDA data

Aura Wellness

Primary DI
00850026680027
Brand
Aura Wellness
Company
Aura Wellness, LLC
Model
Large Loop
Catalog number
aura-lgl-2p/6ft
Device description
The Large Loop PEMF accessory coil is used in conjunction with Aura Wellness line of PEMF therapy devices.
Published
2022-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SGTElectromagnetic Stimulator For Healthy Muscle Stimulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGTElectromagnetic Stimulator For Healthy Muscle StimulationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026680027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026680027008500266800278500266800270850026680027

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 Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
502-514-7996support@aurawell.com

Regulatory Flags#

DUNS number
101299038
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026680072Aura WellnessNova HD+APN-000672023-09-06
00850026680010Aura WellnessButterfly Loopaura-btf-2p/6ft2022-12-13
00850026680034Aura WellnessWingsaura-wings-2p/6ft2022-12-13
00850026680041Aura WellnessHalf Body Mataura-mat-2p/6ft2022-12-13
00850026680188Aura WellnessNova HD+ Starter KitAPN-000532023-09-06
00850026680218Aura WellnessROCROC2026-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850026680072Aura WellnessAura Wellness, LLCSGT2023-09-06
00850026680188Aura WellnessAura Wellness, LLCSGT2023-09-06
00850026680010Aura WellnessAura Wellness, LLCSGT2022-12-13
00850026680034Aura WellnessAura Wellness, LLCSGT2022-12-13
00850026680041Aura WellnessAura Wellness, LLCSGT2022-12-13