Jiajian

Basic Information

• Brand Name: Jiajian
• Primary DI: 08150050225006
• Version / Model: CMNS2-1
• Company Name: Wuxi Jiajian Medical Instrument Co.,Ltd.
• Labeler DUNS: 529966489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-21
• Public Version: 5
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: be1c25f9-4dd7-4abc-a778-6dcd38070656

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BWK	Stimulator, Electro-Acupuncture	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08150050225006	GS1

Premarket Submissions

Submission Number	Supplement Number
K130768	000