Aura Wellness APN-00050

GUDID 00850026680102

The Aura Pulse 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 Pulse 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

Aura Wellness, LLC

Deep-tissue electromagnetic stimulation system, professional
Primary Device ID00850026680102
NIH Device Record Key49a8846f-8a32-4269-b91a-18259a64b9f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAura Wellness
Version Model NumberAura Pulse Starter Kit
Catalog NumberAPN-00050
Company DUNS101299038
Company NameAura Wellness, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com
Phone502-714-1993
Emailsupport@aurawell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 525 Millimeter of Mercury and 795 Millimeter of Mercury
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850026680102 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-23
Device Publish Date2023-10-13

On-Brand Devices [Aura Wellness]

00850026680188The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specific
00850026680157The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits
00850026680140The Aura Wave Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits
00850026680072The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specific
00850026680102The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits
00850026680096The Aura Pulse Pulsed Electromagnetic Field (PEMF) therapy device provides massage-like benefits

Trademark Results [Aura Wellness]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AURA WELLNESS
AURA WELLNESS
90226034 not registered Live/Pending
Aura Wellness, LLC
2020-09-30
AURA WELLNESS
AURA WELLNESS
88364692 not registered Live/Pending
Deondre J Williams
2019-03-31

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