Low-Frequency Therapy Instrument

GUDID 06924607700535

Shenzhen Kentro Medical Electronics Co.,Ltd

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06924607700535
• NIH Device Record Key: 90d57e6e-eb96-4a4e-a569-4d572f4df694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Low-Frequency Therapy Instrument
• Version Model Number: KTR-201
• Company DUNS: 544395368
• Company Name: Shenzhen Kentro Medical Electronics Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06924607700535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170205

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-09-11

On-Brand Devices [Low-Frequency Therapy Instrument]

• 06924607700696: KTR-206
• 06924607700603: KTR-203
• 06924607700580: KTR-202
• 06924607700535: KTR-201