Jiajian

Basic Information

• Brand Name: Jiajian
• Primary DI: 00810011251502
• Version / Model: pointoselect
• 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: 2018-11-12
• Public Version: 2
• Public Version Date: 2019-02-13
• Public Version Status: Update
• Public Device Record Key: fec9a069-2d97-4082-812f-e3a7601b5f93

Device Description

An electronic probe used to precisely locate an acupuncture point on a patient's body.It is used in complemently medicine therapy either independently or with a device intented to apply stilmuli to acupuncture site (e.g., an electrical stimulator). It may include visual or audio singals to indicate the acupuncture point. This is a reusable device.

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: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34497	Acupuncture point detector	An electronic probe used to precisely locate an acupuncture point on a patient's body. It is used in complementary medicine therapy either independently or with a device intended to apply stimuli to acupuncture sites (e.g., an electrical stimulator). It may include visual or audio signals to indicate the acupuncture point. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810011251502	GS1
Package	30810011251503	GS1		20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K123958	000