XFT

GUDID 06970670070044

Shenzhen XFT Electronics Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970670070044
• NIH Device Record Key: 0f3794cc-4d1e-4e64-8a41-ab8b8bae28fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XFT
• Version Model Number: XFT-2001D
• Company DUNS: 526874312
• Company Name: Shenzhen XFT Electronics Co., Ltd.
• 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: 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	06970670070044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162718

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-01-01

Devices Manufactured by Shenzhen XFT Electronics Co., Ltd.

• 06970670070020 - Aspire: 2019-10-23
• 06970670070044 - XFT: 2019-10-23
• 06970670070044 - XFT: 2019-10-23