FDA.reportPublic FDA data

SHENZHEN JINGKEHUI ELECTRONIC

Primary DI
00867587000300
Brand
SHENZHEN JINGKEHUI ELECTRONIC
Company
JKH Health Co., Ltd.
Model
PL-009
Device description
Electronic Pulse Massager - Massager Unit used with pads sold as a single unit per sale.
Published
2017-03-09
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867587000307PackageGS120In Commercial Distribution
00867587000300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086758700030710867587000307
00867587000300008675870003008675870003000867587000300

GMDN Terms#

Term, Definition table
TermDefinition
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
3232321600kschoicorp@gmail.com

Regulatory Flags#

DUNS number
526876993
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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