Nuemedics

GUDID 16971712726100

BLACK COMBO SET

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16971712726100
• NIH Device Record Key: 27f7a8ba-c93f-4883-b5ea-3152bc8a31f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuemedics
• Version Model Number: SM TENS&PMS SM9089
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 12
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	06971712726103 [Primary]
GS1	16971712726100 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220152

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: 2
• Public Version Date: 2025-05-22
• Device Publish Date: 2023-10-12

On-Brand Devices [Nuemedics]

• 10917121000036: TENS
• 06971712720293: TENS
• 06971712726103: SM9089
• 06971712726080: SM9089
• 06971712727575: SM TENS & PMS
• 06971712727551: SM9126
• 06971712727490: SM9128M
• 16971712726100: BLACK COMBO SET
• 16971712726087: BLACK
• 16971712726094: Elite