FDA.reportPublic FDA data

Transcutaneous Electrical Nerve Stimulators

Primary DI
06924607702423
Brand
Transcutaneous Electrical Nerve Stimulators
Company
Shenzhen Kentro Medical Electronics Co.,Ltd
Model
KTR-2640
Published
2021-12-09
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
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
K200177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200177000Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd.2021-03-25NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06924607702423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06924607702423069246077024236924607702423

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
06924607703550Transcutaneous Electrical Nerve StimulatorsKTR-24022026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810093080854PainPodHi-Dow International IncorporatedNGX2026-10-19
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
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., LtdNUH2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17