1BYONE

GUDID 10863696000375

Electronic Pulse Stimulator set

1BYONE PRODUCTS INC.

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: 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)