FDA.reportPublic FDA data

JMOON

Primary DI
16974667825010
Brand
JMOON
Company
Shenzhen Ulike Smart Electronics Co., Ltd.
Model
M30U PR
Published
2025-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K243393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243393000JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.2025-02-03NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974667825010PackageGS18In Commercial Distribution
06974667825013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697466782501016974667825010
06974667825013069746678250136974667825013

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618646978
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
06974667829738UlikeUI06S PRU2026-05-27
06974667829745UlikeUI06S PNU2026-05-27
06974667829752UlikeUI06S WHU2026-05-27
06974667829110UlikeUM102026-03-26
06974667827147UlikeUI06 WH2025-12-10
06974667827154UlikeUI06 PR2025-12-10
06974667827161UlikeUI06 PN2025-12-10
06974667827567UlikeUI20S PW2025-12-10
06974667827574UlikeUI20S GP2025-12-10
06974667827581UlikeUI20 WH2025-12-10
06974667827598Ulike UI20 GR2025-12-10
06974667827604Ulike UI20 BS2025-12-10
06974667827611UlikeUI20 MP2025-12-10
06974667827628UlikeUI20 BL2025-12-10
06974667827635UlikeUI20 PN2025-12-10
06974667827659UlikeUI20 WG2025-12-10
06974667827666UlikeUI20S WH2025-12-10
06974667827680UlikeUI20S BS2025-12-10
06974667827697UlikeUI20S MP2025-12-10
06974667827703UlikeMI01 LP2025-12-10

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
06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
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