FDA.reportPublic FDA data

AVCOO

Primary DI
00860011737988
Brand
AVCOO
Company
ADP HEALTH LIMITED
Model
TU1130
Catalog number
TU1130C12
Device description
TENS:The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.EMS:The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance
Published
2025-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860011737985PackageGS160In Commercial Distribution
00860011737988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001173798510860011737985
00860011737988008600117379888600117379880860011737988

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

Contacts#

Phone, Email table
PhoneEmail
+1-678-8297251support@avcoo.com

Regulatory Flags#

DUNS number
101747972
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073128275AVCOO Adhesive ElectrodesEB2M20EB2M20V0112026-01-28
10850073128272AVCOO Adhesive ElectrodesEB2M20EB2M20V0112026-01-28
00850073128183AVCOOTC1241TC12410Q12025-09-19
00850073128190AVCOOTC2241TC22410Q12025-09-19
10850073128180AVCOOTC1241TC12410Q12025-09-19
10850073128197AVCOOTC2241TC22410Q12025-09-19
00850073128169AVCOOTA2224CTA2224CC112025-09-18
00850073128176AVCOOEB2M20EB2M20C212025-09-18
10850073128166AVCOOTA2224CTA2224CC112025-09-18
10850073128173AVCOOEB2M20EB2M20C212025-09-18
00850073128138AVCOOTS2321AS9020EC142025-08-25
00850073128121AVCOOTS2301AS9020EBC132025-08-25
10850073128135AVCOOTS2321AS9020EC142025-08-25
00850073128107AVCOOTA2224CTA2224CC112025-07-02
10850073128104AVCOOTA2224CTA2224CC112025-07-02
00850073128091AVCOOJT9020E108500731280982025-05-26
00850073128084AVCOOJT9020EAS9020EBC132025-05-26
10850073128098AVCOOJT9020E108500731280982025-05-26
00850073128046AVCOOTU1130TU1130CR22025-04-03
10850073128043AVCOOTU1130TU1130CR22025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09