FDA.reportPublic FDA data

AUVON

Primary DI
06978452680085
Brand
AUVON
Company
Shenzhen Jiantuo Electronics Co., Ltd
Model
JT8012B
Device description
TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS (Electrical Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Published
2026-06-03
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
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
K250053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250053000TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-09NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16978452680082PackageGS148In Commercial Distribution
06978452680085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697845268008216978452680082
06978452680085069784526800856978452680085

Contacts#

Phone, Email table
PhoneEmail
+8675525032034sales5@szastec.com

Regulatory Flags#

DUNS number
625496494
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
06978452680160Zoksi104B2026-09-03
06978452680153NA25082026-08-26
06978452680146MedlinketJT90222026-08-18
06978452680122AUVONJT8012C2026-07-01
06978452680092AUVONJT8012B2026-06-03
06978452680108NURSALJT10652026-06-03
06978452680078AUVONJT8012B2026-05-21
06978452680054HubiCareJT90342026-05-05
06978452680061HubiCareJT9034-KIT2026-05-05
06978452680047NURSALJT10652026-04-13
06978452680023EPULSEPRO 12002025-12-01
06978452680030KONGZEEAS90262025-12-01
16978452680020EPULSEPRO 12002025-12-01
16978452680037KONGZEEAS90262025-12-01
06978452680016NURSALJT90262025-08-21
16978452680013NURSALJT90262025-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971763600889ROOVJOYShenzhen roundwhale technology co. LTD.NGX2026-11-05
06971763600889ROOVJOYShenzhen roundwhale technology co. LTD.NUH2026-11-05
00860015112491Therapist’s Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-11-01
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
00810093080854PainPodHi-Dow International IncorporatedNGX2026-10-19
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988671AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
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., LtdNGX2026-09-03
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18