TechCare

GUDID 10617051000036

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 10617051000036
• NIH Device Record Key: 9c8fa206-3c38-4dd3-a6c7-e89462b27450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TechCare
• 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	10617051000035 [Unit of Use]
GS1	10617051000036 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-04-20

On-Brand Devices [TechCare ]

• 10618022800003: TENS
• 10618013000036: TENS
• 10617101000036: TENS
• 10617061000036: TENS
• 10617051000036: TENS
• 00006853213024: TENS
• 06971712721009: Electrode Pads
• 06971712720279: TENS
• 06971712724765: SM9186
• 06971712724741: SM9587
• 06971712724727: SM9187
• 06971712725533: SM9089
• 06971712725519: SM9089
• 06971712726127: SM9089
• 06971712727537: SM9126
• 06971712727476: SM9128M