AUVON

GUDID 06971712727650

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712727650
• NIH Device Record Key: 7ccbca72-c8bb-442a-8a0f-42a8576ca326
• Commercial Distribution Discontinuation: 2025-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AUVON
• Version Model Number: TENS&EMS
• 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	06971712727650 [Unit of Use]
GS1	16971712727657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220150

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [AUVON]

• 06971712727650: TENS&EMS
• 26971712727654: TENS&EMS
• 26971712727616: TENS&EMS
• 26971712727593: TENS&EMS