FDA.reportPublic FDA data

Procare Tens Machine

Primary DI
00372217037019
Brand
Procare Tens Machine
Company
ARISE MEDICAL LLC
Model
240498
Published
2019-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K130723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130723000FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINALFamidoc Technology Co., Ltd.2014-02-07NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00372217037019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00372217037019003722170370193722170370190372217037019

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081149273
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00372217003014ProCare IR Thermometer2403902018-10-01
00372217036081Safecare Vinyl Exam Gloves2404952023-02-08
00372217036098Safecare Vinyl Exam Gloves2404962023-02-08
00372217036104Safecare Vinyl Exam Gloves2404972023-02-08
00372217036319Safecare Vinyl Exam Gloves2404932023-02-08
00372217036326Safecare Vinyl Exam Gloves2404942023-02-08
00372217003021Procare Forehead Infrared Thermometer240540PG-IRT16022020-07-13
00372217005094Safari Express Pediatric Nebulizer2405382020-08-22
00372217005100Timmy the Tiger Pediatric Nebulizer2405432020-08-22
00372217000013Pro-Care Nebulizer EasyEasy2018-12-01
00372217005018ProCare Nebulizer Basic2403912018-11-22
00372217005025Procare Compact Compressor Nebulizer2403922018-12-21
00372217004035Procare Basic Upper Arm BP Monitor2404842020-08-22
00372217004042Procare Upper Arm BP Monitor with XL Cuff2405312020-08-22
00372217039037Procare Spacer Chamber2405302020-08-22
00372217006015"Ultra-Care Pen Needles 31G 1/4"" 100 Ct"2403932018-11-29
00372217006022"Ultra-Care Pen Needles 31G 3/16"" 100 Ct"2403942018-11-29
00372217006039"Ultra-Care Pen Needles 31G 5/16"" 100 Ct"2403952018-11-29
00372217006046"Ultra-Care Pen Needles 32G 1/4"" 100 Ct"2403962018-11-29
00372217006053"Ultra-Care Pen Needles 32G 3/16"" 100 Ct"2403972018-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850092200006PEPPERPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200013PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200020PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200037PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200044PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200051PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200068PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200075PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200082PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200099PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200105PepperPEPPER INTERACTIVE INC.NGX2026-10-05
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNGX2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21