FDA.report

WITHNIX

Primary DI
08809439110630
Brand
WITHNIX
Company
WITHNIX CO.,LTD
Model
DERMAURA CORE
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications

CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809439110630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809439110630088094391106308809439110630

GMDN Terms

TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods

Method

Regulatory Flags

DUNS number
631093770
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
08809439110623WITHNIXDERMAURA PRO2026-03-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810140063045RENPHO Eye MassagerJoicom CorporationISA2026-05-26
06975617995039SLIMMING TREATMENT DEVICEBEIJING HONKON TECHNOLOGIES CO., LTD.ISA2026-03-23
04055207069226NARichard Wolf GmbHISA2026-03-12
04055207069257NARichard Wolf GmbHISA2026-03-12
08809439110623WITHNIXWITHNIX CO.,LTDISA2026-03-06
07630039101909MASTERPULS®Storz Medical AGISA2026-03-01
08057592610676IcooneI-TECH INDUSTRIES SRLISA2026-02-19
08800250280694QuadtheraECO DM LAB Co., Ltd.ISA2026-02-16
06973134771549silverfoxSilverfox Corporation LimitedISA2026-02-05
00851439007135PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007142PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007159PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007166PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007173PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007180PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007197PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007203PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00031262120243HomedicsHealth Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.ISA2026-01-15
08806109104555Centellian24 MADECA PRIME RITUAL WHITE PEARLDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
08806109105422Centellian24 MADECA PRIME MAXDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
10810140062892RENPHOJoicom CorporationISA2026-01-04
10810140062861RENPHOJoicom CorporationISA2025-12-16
08436560853152ToskaniTOSKANI SL.ISA2025-12-12
08436560853169ToskaniTOSKANI SL.ISA2025-12-12
10810140062854RENPHOJoicom CorporationISA2025-12-03
06970441320132AquafirmeXSBeijing Anchorfree Technology Co., Ltd.ISA2025-09-23
05391540830833Préime DermaFacialEMA AESTHETICS LIMITEDISA2025-09-15
10810140062670RENPHOJoicom CorporationISA2025-09-11
00860010877487WavonEase Seating SystemsISA2025-09-08
04262477320197SONOGELE.M.S. Electro Medical Systems S.A.ISA2025-09-02