Solaris

GUDID 06971712726691

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712726691
• NIH Device Record Key: 0b481f91-2781-45f2-aebf-114b43300974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solaris
• Version Model Number: SM9126
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 24
• 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	06971712726684 [Primary]
GS1	06971712726691 [Unit of Use]

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: 2024-04-15
• Device Publish Date: 2024-04-05

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 06971712726745 - MASTOGO: 2024-04-22
• 06971712726585 - Chirp: 2024-04-18
• 06971712726608 - Chirp: 2024-04-18
• 06971712726691 - Solaris: 2024-04-15
• 06971712726691 - Solaris: 2024-04-15
• 06971712726523 - NeuroMD: 2024-04-08
• 06971712726622 - VPOD: 2024-04-01
• 06971712726646 - Belifu: 2024-03-18
• 06971712726660 - Belifu: 2024-03-18