DERMA DONUT

GUDID 06971712725397

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712725397
• NIH Device Record Key: 77343788-916d-4ce7-a853-88446c6f793f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMA DONUT
• Version Model Number: SM9187
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 60
• 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	06971712725397 [Unit of Use]
GS1	06971712725403 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 16971712724656 - Belifu: 2025-09-11 RED
• 06971712720057 - NEOCARBON: 2025-09-08
• 16971712725073 - Copper life: 2025-09-04
• 06971712720248 - NEOCARBON: 2025-08-21
• 06971712727360 - DotsGeek: 2025-08-21
• 16971712720238 - KorShoe: 2025-08-20
• 16971712724717 - Unimed: 2025-08-19 Wireless
• 06971712720224 - mediliev: 2025-08-13