Numiere

GUDID 16971712722973

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16971712722973
• NIH Device Record Key: 5ade53ab-ba77-41e3-b092-a0d845f13702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Numiere
• Version Model Number: SM9916
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 12
• 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	06971712722976 [Primary]
GS1	16971712722973 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171821

FDA Product Code

• NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-02-12
• Device Publish Date: 2022-11-18

On-Brand Devices [Numiere]

• 6971712722976: SM9916
• 06971712725267: SM9920
• 16971712722973: SM9916