Sinrel

GUDID 16975785860037

TENS & PMS Unit

Shenzhen Yuehua Xinsen Technology Co., Ltd.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 16975785860037
• NIH Device Record Key: a2f4168b-5947-4d65-90d6-8d6d05e7fc90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinrel
• Version Model Number: YF1504V
• 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	06975785860030 [Primary]
GS1	16975785860037 [Package]; Contains: 06975785860030; Package: Carton [32 Units]; In Commercial Distribution
GS1	26975785860034 [Package]; Contains: 06975785860030; Package: Carton [36 Units]; In Commercial Distribution
GS1	36975785860031 [Package]; Contains: 06975785860030; 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: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Sinrel]

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