FDA.reportPublic FDA data

Revitive Circulation Booster

Primary DI
00858058005016
Brand
Revitive Circulation Booster
Company
ACTEGY LIMITED
Model
RIX
Catalog number
1718
Device description
Neuromuscular Electrical Stimulation Device
Published
2018-04-23
Public version status
Update
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143207000Revitive IX (OTC)Actegy , Ltd.2015-03-23NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858058005013PackageGS16In Commercial Distribution
00858058005016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085805800501310858058005013
00858058005016008580580050168580580050160858058005016

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous electrical stimulation system, line-poweredAn assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8772603114us.info@actegy.com

Regulatory Flags#

DUNS number
735575941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858058005108Revitive EssentialRLV24522020-09-24
00858058005184Revitive Medic Knee2836AB57372020-09-24
00858058005221Revitive Medic Coach5575AQ59212022-01-28
00858058005238Revitive Medic5573AQ59702021-01-19
00858058005252Revitive ProHealth5572AQ63022021-01-21
10858058005228Revitive Medic Coach5575AQ59212022-01-28
05060217490303Revitive Electrode Body Pads20442021-05-04
05060217493571Revitive Arthritis Knee Pads293929392020-07-28
00858058005047Aerosure3481AJ14742021-05-04
10858058005044Aerosure3481AJ14742021-05-04
05060217492130Revitive Electrode Body Pads20442021-05-04
00858058005023Revitive Electrode Body Pads157015702018-04-23
10858058005259Revitive ProHealth5572AQ63022021-01-21
10858058005235Revitive Medic5573AQ59702021-01-19
10858058005105Revitive EssentialRLV24522020-09-24
10858058005181Revitive Medic Knee2836AB57372020-09-24
05060217493588Revitive Arthritis Knee Pads293929392020-07-28
00858058005146Revitive Medic Plus3156AD31582019-10-09
10858058005143Revitive Medic Plus3156AD31582019-10-09
00858058005085Revitive Medic2469MD26162018-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
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
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11