Sinrel

GUDID 16975785860006

TENS & PMS Unit

Shenzhen Yuehua Xinsen Technology Co., Ltd.

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 16975785860006
• NIH Device Record Key: 2cc4f6c5-4150-4ec2-9e88-8632314e874b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinrel
• Version Model Number: YF1503
• Company DUNS: 417886675
• Company Name: Shenzhen Yuehua Xinsen Technology 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: false
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975785860009 [Primary]
GS1	16975785860006 [Package]; Contains: 06975785860009; Package: Carton [32 Units]; In Commercial Distribution
GS1	26975785860003 [Package]; Contains: 06975785860009; Package: Carton [36 Units]; In Commercial Distribution
GS1	36975785860000 [Package]; Contains: 06975785860009; Package: Carton [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220005

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-03
• Device Publish Date: 2023-03-26

On-Brand Devices [Sinrel]

• 16975785860037: TENS & PMS Unit
• 16975785860006: TENS & PMS Unit