FDA.reportPublic FDA data

Transcutaneous Electrical Nerve Stimulators

Primary DI
06924607703550
Brand
Transcutaneous Electrical Nerve Stimulators
Company
Shenzhen Kentro Medical Electronics Co.,Ltd
Model
KTR-2402
Published
2026-07-31
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYGLapping Tool Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYGLapping Tool KitDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232517000Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)Shenzhen Kentro Medical Electronics Co., Ltd.2023-12-08NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06924607703550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06924607703550069246077035506924607703550

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.

Regulatory Flags#

DUNS number
544395368
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
06924607702997kentroKTR-23012026-04-30
06924607703000kentroKTR-23022026-04-22
06924607703017kentroKTR-23412026-04-22
06924607703024kentroKTR-23422026-04-22
06924607703031kentroKTR-24012026-04-22
06924607703048kentroKTR-24022026-04-22
06924607703055kentroKTR-24112026-04-22
06924607703062kentroKTR-24122026-04-22
06924607703079kentroKTR-24912026-04-22
06924607703086kentroKTR-24922026-04-22
06924607703093kentroKTR-24932026-04-22
06924607703109kentroKTR-24942026-04-22
06924607703253Dr franklyKTR-24922026-04-22
06924607703284smart stimKTR-24922026-04-22
06924607703390vastlandKTR-24922026-04-22
06924607703437Dr franklyKTR-24922026-04-22
06924607703413Transcutaneous Electrical Nerve StimulatorsKTR-2062026-04-14
06924607703420Transcutaneous Electrical Nerve StimulatorsKTR-2092026-04-14
06924607702959Transcutaneous Electrical Nerve Stimulator For Pain Relief KTR-24012024-12-17
06924607702966Transcutaneous Electrical Nerve Stimulator For Pain Relief KTR-24022024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
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
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27