Unimed

GUDID 00609224275852

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00609224275852
• NIH Device Record Key: e48b4339-ef72-4a43-a597-11a9d7d840c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unimed
• 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	00609224275852 [Primary]
GS1	10609224275852 [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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-12-07

On-Brand Devices [Unimed]

• 00609224275852: TENS
• 10818013000036: TENS
• 10817101000036: TENS
• 10817061000036: TENS
• 10717051000036: TENS
• 06971712724789: SM9186
• 06971712726240: TENS
• 06971712727469: SM9128M
• 06971712727513: SM9126