takoo

GUDID 06971712729944

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712729944
• NIH Device Record Key: 45a69c6c-89da-4c3a-95f3-a496653dae73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: takoo
• Version Model Number: SM9126
• 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: false
• 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	06971712729944 [Unit of Use]
GS1	06971712729951 [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: 2025-01-30
• Device Publish Date: 2025-01-22

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 06971712722082 - Criterion: 2026-01-14
• 06971712723027 - DOMAS: 2026-01-14
• 06971712725915 - DOMAS: 2026-01-14
• 06971712726387 - CQJCTCL: 2026-01-14
• 06971712726400 - CQJCTCL: 2026-01-14
• 06971712722587 - CESLIFF: 2026-01-13 BLACK
• 16971712720122 - Procomfort: 2025-12-18
• 16971712725110 - DOMAS: 2025-12-17