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 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 IDB786SBM1AA0170
NIH Device Record Keya4902d67-a86f-4837-8968-86597f3b21b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameactiTENS
Version Model NumberactiTENS standard kit
Catalog NumberSBM1AA017
Company DUNS267525498
Company NameSUBLIMED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB786SBM1AA0170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-02
Device Publish Date2024-04-24

On-Brand Devices [actiTENS]

B786SBM2AA2100actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana
B786SBM2AA1100actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana
B786SBM1AF1100The charging case ensures the charging of the actiTENS Electric impulse generator.
B786SBM1AB0110The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhes
B786SBM1AA1100actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana
B786SBM1AA0170actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to mana

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.