FDA.reportPublic FDA data

Electronic Stimulator

Primary DI
06974700021112
Brand
Electronic Stimulator
Company
Shenzhen Leqing Medical Instrument Co., LTD
Model
uLumb-9533A
Device description
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.Note1: The electrode on the stimulator is used in the waist.Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg.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
06974700021112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974700021112069747000211126974700021112

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
06974700021051Electronic StimulatoruNeck-9521A2023-05-17
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
06974700021129Electronic StimulatorLQ-9525B2023-05-17

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