FDA.reportPublic FDA data

Transcutaneous Electrical Nerve Stimulator For Pain Relief

Primary DI
06924607702973
Brand
Transcutaneous Electrical Nerve Stimulator For Pain Relief
Company
Shenzhen Kentro Medical Electronics Co.,Ltd
Model
KTR-2411
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

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
06924607702973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06924607702973069246077029736924607702973

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544395368
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
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
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11