actiTENS SBM1AB011

GUDID B786SBM1AB0110

The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhesive trip made of a silicone-based adhesive. The self-adhesive strip is intended to be placed on any part of the body but not on injured or irritated skin. The purpose of the self-adhesive strip is to maintain the actiTENS electric impulse generator near the part of the body which the patient wants to stimulate.

SUBLIMED

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: B786SBM1AB0110
• NIH Device Record Key: 74a6e0cd-ed40-45a9-88dd-bf0e22165e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: actiTENS
• Version Model Number: actiTENS self-adhesive strips
• Catalog Number: SBM1AB011
• Company DUNS: 267525498
• Company Name: SUBLIMED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B786SBM1AB0110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202159

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2024-05-02
• Device Publish Date: 2024-04-24

On-Brand Devices [actiTENS]

• B786SBM2AA2100: actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana
• B786SBM2AA1100: actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana
• B786SBM1AF1100: The charging case ensures the charging of the actiTENS Electric impulse generator.
• B786SBM1AB0110: The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhes
• B786SBM1AA1100: actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana
• B786SBM1AA0170: actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana