Low-Frequency Therapy Instrument

GUDID 06970651383224

Shenzhen NearbyExpress Technology Development Company Limited

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06970651383224
• NIH Device Record Key: ce42ab7c-79de-472f-b845-ec190bae36fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Low-Frequency Therapy Instrument
• Version Model Number: SA-PCA008
• Company DUNS: 421320739
• Company Name: Shenzhen NearbyExpress Technology Development Company Limited
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	06970651383224 [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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-09-06

Devices Manufactured by Shenzhen NearbyExpress Technology Development Company Limited

• 06970651383224 - Low-Frequency Therapy Instrument: 2019-10-23
• 06970651383224 - Low-Frequency Therapy Instrument: 2019-10-23
• 06970651384658 - TAOTRONICS Wireless Body Composition Smart Scale: 2018-03-29