FDA.reportPublic FDA data

Nuon

Primary DI
06977168990013
Brand
Nuon
Company
Shenzhen Nuon Medical Equipment Co., Ltd.
Model
HD-44
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251034000Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)Shenzhen Nuon Medical Equipment Co., Ltd.2025-10-12NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977168990013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977168990013069771689900136977168990013

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held deep-tissue electromagnetic stimulatorA battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.

Regulatory Flags#

DUNS number
638546324
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977168990129NuonHD-702026-04-21
06977168990143NuonHD-53A2026-04-21
06977168990150NuonHD-59A2026-04-21
06977168990167NuonHD-722026-04-21
06977168990174NuonHD-73A2026-04-21
06977168990181NuonHD-1162026-04-21
06977168990198NuonHD-53B2026-04-21
06977168990204NuonHD-72A2026-04-21
06977168990211NuonHD-73B2026-04-21
06977168990228NuonHD-116A2026-04-21
06977168990273NuonHD-59B2026-04-21
06977168990334NuonHD-59D2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851367006224ZIIP BeautyZIIP, INC.NFO2026-04-22
00851530007621AvazziaAVAZZIA INCNFO2026-04-21
00851530007638AvazziaAVAZZIA INCNFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDNFO2025-08-07
00817076014516bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014523bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014530bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
08908008085499Syrma Johari MedTech LimitedSYRMA JOHARI MEDTECH LIMITEDNFO2025-07-08
06974667825013JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825020JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825037JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825044JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825051JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07