Unimed

GUDID 06971712727469

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712727469
• NIH Device Record Key: 4b55be32-4dde-4632-9701-37f56dc15eec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unimed
• Version Model Number: SM9128M
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971712727452 [Unit of Use]
GS1	06971712727469 [Primary]
GS1	16971712727466 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121719
• Premarket Notification: K233092

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: 9
• Public Version Date: 2024-10-29
• Device Publish Date: 2018-01-08

On-Brand Devices [Unimed]

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