FDA.reportPublic FDA data

Aura Wellness

Primary DI
00850026680072
Brand
Aura Wellness
Company
Aura Wellness, LLC
Model
Nova HD+
Catalog number
APN-00067
Device description
The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designedspecifically for the Human Healthcare Market. Using state of the art design concepts and HumanFactor Principles, the Nova HD+ is easy to operate and incorporates many features to improve orfacilitate muscle performance.The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improveor facilitate muscle performance.
Published
2023-09-06
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
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220938000Nova HD+Aura Wellness, LLC2023-08-22NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026680072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026680072008500266800728500266800720850026680072

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
Serial number
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
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03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNGX2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNGX2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00850073128138AVCOOADP HEALTH LIMITEDNGX2025-08-25
00850073128121AVCOOADP HEALTH LIMITEDNGX2025-08-25
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00850073128107AVCOOADP HEALTH LIMITEDNGX2025-07-02
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
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