AccessGUDID - DEVICE: SHENZHEN JINGKEHUI ELECTRONIC (00867587000300)

GUDID

Device Identifier (DI) Information

Brand Name: SHENZHEN JINGKEHUI ELECTRONIC
Version or Model: PL-009
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JKH Health Co., Ltd.

Primary DI Number: 00867587000300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 526876993 *Terms of Use

Device Description: Electronic Pulse Massager - Massager Unit used with pads sold as a single unit per sale.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36560	Hand-held electric massager	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c21f4f87-9eae-4a9d-8396-7e4a9a206ecf
Public Version Date: August 20, 2020
Public Version Number: 5
DI Record Publish Date: March 09, 2017