EPULSE

GUDID 16978452680020

TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS (Electrical Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Shenzhen Jiantuo Electronics Co., Ltd

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16978452680020
• NIH Device Record Key: 2d00b952-c243-4174-bb97-f4f71f6b8804
• Commercial Distribution Discontinuation: 2030-12-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPULSE
• Version Model Number: PRO 1200
• Company DUNS: 625496494
• Company Name: Shenzhen Jiantuo Electronics Co., Ltd
• Device Count: 1
• 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: false
• 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

Customer Support Contacts

• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com
• Phone: +8618145850692
• Email: Sales7@szastec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06978452680023 [Primary]
GS1	16978452680020 [Package]; Contains: 06978452680023; Package: carton [36 Units]; Discontinued: 2025-12-02; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250360

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by Shenzhen Jiantuo Electronics Co., Ltd

• 16978452680020 - EPULSE: 2025-12-09TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS (Electrical Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
• 16978452680020 - EPULSE: 2025-12-09 TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscl
• 16978452680037 - KONGZEE: 2025-12-09 TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscl
• 16978452680013 - NURSAL: 2025-08-29 TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscl