FDA.report

AUVON

Primary DI
00850080988466
Brand
AUVON
Company
UAN HEALTHCARE LIMITED
Model
TA2224
Device description
The devices of this submission are designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.
Published
2026-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications

CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850080988463PackageGS160In Commercial Distribution
00850080988466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085008098846310850080988463
00850080988466008500809884668500809884660850080988466

GMDN Terms

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.

Contacts

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
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 DIBrandModelCatalogPublished
10850080988142AUVONTX62242026-03-23
10850080988135AUVONTP2408C2026-03-19
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 DIBrandCompanyProduct codePublished
06971712727704YUN MANSIONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-26
06971712727704YUN MANSIONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-26
10850080988142AUVONUAN HEALTHCARE LIMITEDNGX2026-03-23
10850080988135AUVONUAN HEALTHCARE LIMITEDNGX2026-03-19
06932307410418JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.NUH2026-03-04
16971712724502LILAHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-03-03
00714905710024Fab StimCOMPASS HEALTH BRANDS CORP.NUH2026-02-06
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
06971292004301AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2026-01-21
00850016867407Pixie CupPixie Cup LLCNUH2026-01-09
06950940802810N/AShenzhen Osto Technology Co.,Ltd.NGX2025-12-19
06971292004295AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-12-17
06950940802773N/AShenzhen Osto Technology Co.,Ltd.NGX2025-12-10
16971712720122ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-12-10
00810093080786PainPod Hi-Dow International IncorporatedNUH2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNUH2025-12-09
10860015112405TENSnet 3MTCLINICAL HEALTH SERVICES, INC.NGX2025-12-05
04719871185605iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
04719871186039EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
16978452680020EPULSEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
16978452680037KONGZEEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
00850022650543Motive Lower Back SystemMotive Health, Inc.NGX2025-11-28
06971292004127AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-22
10850073128180AVCOOADP HEALTH LIMITEDNUH2025-09-19
10850073128197AVCOOADP HEALTH LIMITEDNUH2025-09-19
16971292004117AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-19
10850073128166AVCOOADP HEALTH LIMITEDNUH2025-09-18