Procomfort

GUDID 16971712720122

Hong Qiangxing (Shen Zhen) Electronics Limited

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 16971712720122
• NIH Device Record Key: 72d8aaa3-b5b4-496d-b1eb-f27720f6ef22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procomfort
• Version Model Number: SM9075
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 1
• DM Exempt: false
• 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: 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	06971712720125 [Primary]
GS1	16971712720122 [Package]; Contains: 06971712720125; Package: [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 16971712720122 - Procomfort: 2025-12-18
• 16971712720122 - Procomfort: 2025-12-18
• 16971712725110 - DOMAS: 2025-12-17
• 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