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

• 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