Stimease

GUDID 06971712721627

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712721627
• NIH Device Record Key: 3e86f8f7-58f4-466a-92d3-5e911840efb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stimease
• Version Model Number: TENS
• 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: 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	06971712721627 [Unit of Use]
GS1	06971712721634 [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: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [Stimease]

• 06971712721276: TENS
• 06971712721603: TENS
• 06971712721627: TENS
• 06971712721313: TENS
• 06971712721290: TENS
• 06971712721900: TENS
• 06971712721986: SM9126
• 06971712721962: SM9126
• 06971712722136: SM9126
• 06971712721924: SM9126
• 06971712722150: SM9126
• 06971712721948: SM9126
• 06971712726431: SM9126
• 06971712726417: SM9126
• 06971712726394: SM9126
• 06971712727162: TENS
• 06971712727148: TENS