Xpoint

GUDID 10325190124020

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 10325190124020
• NIH Device Record Key: 60536be5-a995-4944-a0e8-9135096ca89b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xpoint
• Version Model Number: TENS
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 36
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	10325190124020 [Primary]
GS1	19012402019113 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121719

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2019-03-25

On-Brand Devices [Xpoint]

• 10325190124020: TENS
• 15192003110304: TENS
• 15192001150098: TENS
• 06971712728107: TENS
• 06971712728121: TENS
• 06971712728442: TENS
• 71056191106203: TENS
• 06971712728640: TENS
• 06971712728787: TENS
• 06971712728947: TENS
• 06971712729043: Electrode pad
• 06971712729616: TENS
• 06971712729999: SM9126
• 06971712729975: SM9126
• 06971712727056: TENS