FDA.reportPublic FDA data

Electronic Stimulator

Primary DI
06974700021051
Brand
Electronic Stimulator
Company
Shenzhen Leqing Medical Instrument Co., LTD
Model
uNeck-9521A
Device description
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.Heating: To be used for temporary relief of minor aches and pains.
Published
2023-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223428000Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)Shenzhen Leqing Medical Instrument Co., Ltd.2023-05-08NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974700021051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974700021051069747000210516974700021051

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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
710753231
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974700021006Electronic StimulatoruNeck-9512A2023-05-17
06974700021013Electronic StimulatoruNeck-9515A2023-05-17
06974700021020Electronic StimulatoruNeck-9517B2023-05-17
06974700021037Electronic StimulatoruNeck-9518A2023-05-17
06974700021044Electronic StimulatoruNeck-9519A2023-05-17
06974700021068Electronic StimulatoruNeck-9529A2023-05-17
06974700021075Electronic Stimulator LQ-9535A2023-05-17
06974700021082Electronic StimulatoruLumb-9530A2023-05-17
06974700021099Electronic StimulatoruLumb-9531A2023-05-17
06974700021105Electronic StimulatoruLumb-9532A2023-05-17
06974700021112Electronic StimulatoruLumb-9533A2023-05-17
06974700021129Electronic StimulatorLQ-9525B2023-05-17

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