FDA.reportPublic FDA data

AVCOO

Primary DI
10850073128043
Brand
AVCOO
Company
ADP HEALTH LIMITED
Model
TU1130
Catalog number
TU1130CR2
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
2025-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850073128043PackageGS160Not in Commercial Distribution
00850073128046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007312804310850073128043
00850073128046008500731280468500731280460850073128046

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00850073128008AVCOOTA2224CTA2224CC122025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988442AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988459AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
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00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
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00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11