FDA.reportPublic FDA data

Revitive Medic Knee

Primary DI
10858058005181
Brand
Revitive Medic Knee
Company
ACTEGY LIMITED
Model
2836AB
Catalog number
5737
Device description
Neuromuscular Electrical Stimulation Device
Published
2020-09-24
Public version status
New
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190924000Revitive Medic Plus, Revitive Advanced 2Actegy , Ltd.2019-07-05NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858058005181PackageGS16In Commercial Distribution
00858058005184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085805800518110858058005181
00858058005184008580580051848580580051840858058005184

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
735575941
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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
05060217493588Revitive Arthritis Knee Pads293929392020-07-28
00858058005146Revitive Medic Plus3156AD31582019-10-09
10858058005143Revitive Medic Plus3156AD31582019-10-09
00858058005016Revitive Circulation BoosterRIX17182018-04-23
00858058005085Revitive Medic2469MD26162018-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
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00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNUH2026-06-24
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28