FDA.reportPublic FDA data

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

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
10850080988463PackageGS160In Commercial Distribution
00850080988466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085008098846310850080988463
00850080988466008500809884668500809884660850080988466

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.

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
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
00850080988671AUVONTU10802026-10-08
00850080988688AUVONTU10802026-10-08
00850080988695AUVONTU10802026-10-08
00850080988718AUVONEB15722026-10-08
00850080988640AUVONEP3M122026-07-22
00850080988657AUVONTP2408C2026-07-22
00850080988633AUVONEB10242026-07-17
00850080988602AUVONEB1M362026-07-16
00850080988619AUVONEP3M122026-07-16
00850080988626AUVONEP37082026-07-16
00850080988589AUVONEP3M122026-07-14
00850080988572AUVONTP22082026-07-03
00850080988473AUVONTA32242026-06-24
00850080988435AUVONTA22242026-05-21
00850080988442AUVONTX62242026-05-21
00850080988459AUVONTX62242026-05-21
00850080988428AUVONDS-W2026-05-09
00850080988411AUVONTU24242026-05-06
00850080988381AUVONTA22242026-04-29
00850080988398AUVONTX62242026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 LIMITEDNGX2026-10-08
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
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., LtdNUH2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17