iTENS

GUDID 06942808221055

iTENS is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

EasyMed Instruments Co., Ltd.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06942808221055
• NIH Device Record Key: f65e0b4d-9e37-4cda-abd6-d544a913d857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTENS
• Version Model Number: iTENS
• Company DUNS: 526951168
• Company Name: EasyMed Instruments 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942808221055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143430

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: 2024-01-26
• Device Publish Date: 2024-01-18

Devices Manufactured by EasyMed Instruments Co., Ltd.

• 06942808291478 - IF-4 MultiWave: 2024-01-29 EMS stands for Electrical Neuromuscular Stimulator. The IF-4 MultiWave EMS system is indicated for: • Relaxation of muscle spa
• 06942808221055 - iTENS: 2024-01-26iTENS is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
• 06942808221055 - iTENS: 2024-01-26 iTENS is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain f
• 06942808241015 - KGL-1400-F: 2021-11-25 KGL-1400-F is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to str
• 06942808261013 - Ultima Combo: 2021-11-25 Ultima Combo is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute
• 06942808261020 - Relief Combo: 2021-11-25 Relief Combo is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute
• 06942808291027 - Parasym: 2021-11-25 Parasym is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or
• 06942808221031 - TENS U5: 2021-11-23 TENS U5 is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or p
• 06942808221048 - Ultima 20: 2021-11-23 Ultima 20 is a Transcutaneous Electrical Nerve Stimulator which is used to provide symptomatic pain relief for chronic, acute or