AccessGUDID - DEVICE: Jiajian (08150050225006)

GUDID

Device Identifier (DI) Information

Brand Name: Jiajian
Version or Model: CMNS2-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wuxi Jiajian Medical Instrument Co.,Ltd.

Primary DI Number: 08150050225006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529966489 *Terms of Use

Device Description: Needle Stimulator is combined with modern micro computer high-new technique, traditional Chinese medicine acupuncture and meridian theory,based on the traditional electronic acupuncture treatment instrument. The product is used for applying low frequency pulse to stimulate the acupoints of human body.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
58832	Migraine-therapy peripheral nerve electrical stimulator	A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWK	Stimulator, Electro-Acupuncture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130768	000

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: be1c25f9-4dd7-4abc-a778-6dcd38070656
Public Version Date: October 23, 2019
Public Version Number: 5
DI Record Publish Date: October 21, 2016