KegelHard

GUDID 06971712729142

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712729142
• NIH Device Record Key: d4deed73-e871-48fc-8eec-25864f87c54c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KegelHard
• Version Model Number: TENS unit
• 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	06971712729135 [Primary]
GS1	06971712729142 [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: 2021-08-17
• Device Publish Date: 2021-08-09

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 16971712726094 - Nuemedics: 2025-05-29 Elite
• 16971712724748 - Techcare: 2025-05-22 Touch X
• 16971712724786 - Unimed: 2025-05-22 Pro X
• 16971712726087 - Nuemedics: 2025-05-22 BLACK
• 16971712726100 - Nuemedics: 2025-05-22 BLACK COMBO SET
• 16971712720276 - Techcare: 2025-05-21 BLACK
• 16971712724724 - Techcare: 2025-05-21 BLACK COMBO SET
• 16971712725509 - Techcare: 2025-05-21 RED