1BYONE

GUDID 10863696000375

Electronic Pulse Stimulator set

1BYONE PRODUCTS INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 10863696000375
• NIH Device Record Key: 69bd7011-c8dc-47de-977e-34fa15b8f75a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1BYONE
• Version Model Number: PL-029K8(725EU-0001)
• Company DUNS: 845019202
• Company Name: 1BYONE PRODUCTS INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863696000361 [Primary]
GS1	00863696000378 [Package]; Contains: 00863696000361; Package: gift box [1 Units]; In Commercial Distribution
GS1	10863696000375 [Package]; Contains: 00863696000378; Package: Outer carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153520

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2017-05-24

On-Brand Devices [1BYONE]

• 10863696000375: Electronic Pulse Stimulator set
• 10863696000351: Infrared Thermometer
• 10863696000337: Pulse Oximeter
• 00863696000309: Arm blood pressure monitor
• 20858069007058: TOUCH-FREE INFRARED THERMOMETER - 4 in 1 Function : Forehead/Object/Night Mode/Back Light - Me
• 10858069007044: Wireless Arm Blood Pressure Monitor
• 10858069007020: Electronic Pulse Stimulator Replacement Pads 4x4cm
• 10863696000399: Electronic Pulse Stimulator Replacement Pads set of 3
• 00850014261016: TMB-1585-BS
• 10858069007129: PL-029K16B
• 00858069007085: Two different size pads, one is 4*4 cm pad ( 4 pieces) one is big pad. ( 1 pieces)