FDA.reportPublic FDA data

AUVON

Primary DI
10850080988135
Brand
AUVON
Company
UAN HEALTHCARE LIMITED
Model
TP2408C
Device description
Transcutaneous Electrical Nerve Stimulation (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. Electrical Muscle Stimulation (EMS): The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Published
2026-03-19
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
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850080988135PackageGS132In Commercial Distribution
00850080988138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085008098813510850080988135
00850080988138008500809881388500809881380850080988138

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)829-7256support@iauvon.com

Regulatory Flags#

DUNS number
765349382
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
00850080988466AUVONTA22242026-05-24
10850080988142AUVONTX62242026-03-23
00850080988107AUVONDS-W2026-03-02
00850080988114AUVONDS-W2026-03-02
00850080988121AUVONEB15482026-03-02
00850080988046AUVONDS-W2026-02-06
00850080988077AUVONDS-W2026-02-06
00850080988091AUVONDS-W2026-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712727704YUN MANSIONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-26
00850080988466AUVONUAN HEALTHCARE LIMITEDNGX2026-05-24
10850080988142AUVONUAN HEALTHCARE LIMITEDNGX2026-03-23
16971712724502LILAHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-03-03
07290018152164Pure ImpactSOFWAVE MEDICAL LTDNGX2026-02-01
16973810850435BelifuShenzhen Jian Feng Electronic Technology Co., Ltd.NGX2026-01-29
08059916140005Limfa Therapy System (Limfa Therapy)EYWA SRLNGX2026-01-29
00199874173993Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-01-22
06950940802810N/AShenzhen Osto Technology Co.,Ltd.NGX2025-12-19
06950940802773N/AShenzhen Osto Technology Co.,Ltd.NGX2025-12-10
16971712720122ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-12-10
10860015112405TENSnet 3MTCLINICAL HEALTH SERVICES, INC.NGX2025-12-05
00850022650543Motive Lower Back SystemMotive Health, Inc.NGX2025-11-28
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NGX2025-09-11
00810113683379DualPulse CompactManamed, Inc.NGX2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NGX2025-09-11
07290018152171Pure Impact Touch control ModuleSOFWAVE MEDICAL LTDNGX2025-09-08
06971712720057NEOCARBONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-31
16971712725073Copper lifeHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-27
00850998008539ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00199284950719NXProNeux Technologies, Inc.NGX2025-08-19
06971712723621BELIFUHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712723645NURSALHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712720590TENKERHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712720613TECBEANHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712720637NURSALHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712721856BELIFUHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712723799BELIFUHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712723638BELIFUHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05
06971712723652BELIFUHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-08-05