XFT, SaeboStim Pro

GUDID 06970670070228

Shenzhen XFT Medical Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970670070228
• NIH Device Record Key: 56d2bdcc-afb6-4c76-9784-3301f94ff3a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XFT, SaeboStim Pro
• Version Model Number: XFT-2000, SaeboStim Pro
• Company DUNS: 526874312
• Company Name: Shenzhen XFT Medical 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970670070228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193275

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2021-02-19
• Device Publish Date: 2020-06-02