iSelfCare

GUDID 00147753462508

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00147753462508
• NIH Device Record Key: 42936fff-ac83-4c3e-a6d4-2c8f2bf8dd73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSelfCare
• Version Model Number: TENS
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 45
• DM Exempt: false
• 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: true
• 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	00147753462508 [Primary]
GS1	00147753462509 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-10-25

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 06971712729944 - takoo: 2025-01-30
• 16971712727466 - NURSAL: 2025-01-09 HPTS0237 silver
• 06971712727759 - Cloudix: 2025-01-08
• 06971727219706 - eMP10: 2025-01-08
• 06971712729647 - TOMMIE COPPER: 2024-12-11
• 06971712727452 - TEC.BEAN: 2024-12-10
• 06971712727483 - TENKER: 2024-12-10 PURPLE
• 06971712727506 - NUSRAL: 2024-12-10 black