actiTENS SBM1AA017

GUDID B786SBM1AA0170

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.

SUBLIMED

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: B786SBM1AA0170
• NIH Device Record Key: a4902d67-a86f-4837-8968-86597f3b21b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: actiTENS
• Version Model Number: actiTENS standard kit
• Catalog Number: SBM1AA017
• Company DUNS: 267525498
• Company Name: SUBLIMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B786SBM1AA0170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202159

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: 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