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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
actiTENS standard kit
In Commercial Distribution
- 03770018808239 ()
SBM1AA018
- Analgesic transcutaneous electrical nerve stimulation system
"The Myolift QT+ is a Microcurrent, handheld, and mobile application based device, and easy to operate. The application used with this device
will support both the types of users iPhone® and Android™. The User has to download the application via Google Play™ store (Android) /App
Store® (iOS) and connect the device via Bluetooth of their phone and
make their profiles accordingly.
The purpose of this device is to lift and tone the face and neck. It is a
battery-powered device used with conductive gel. The conductive gel is
used to reduce the impedance between the electrodes and the skin of the
user.
Myolift QT+ has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port"
SYRMA JOHARI MEDTECH LIMITED
Myolift QT+
In Commercial Distribution
- 08908008085499 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
Expand your communication options with a set of three BIG TalkingBrix speech devices. Pressing the large colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Add strategically around the classroom or home to provide on-the-spot communication
Use together to make choices
Use with multiple individuals at one time to provide each with a unique communication message
Features
High-quality sound suitable for almost any environment
Long-lasting rechargeable battery
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the BIG TalkingBrix. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device
Ablenet, Inc.
10000050
In Commercial Distribution
- 00850011150184 ()
10000050
- Assistive speech generator
Expand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Add strategically around the classroom or home to provide on-the-spot communication
Use together to make choices
Use with multiple individuals at one time to provide each with a unique communication message
Features
High-quality sound suitable for almost any environment
Long-lasting rechargeable battery
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000032
In Commercial Distribution
- 00186648000524 ()
10000032
- Assistive speech generator
The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Use for yes and no responses
Choose between two options of food, drink, or activities
Provide a way to make two unique requests like "I need help" and "I'm done"
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000045
In Commercial Distribution
- 00850011150108 ()
10000045
- Assistive speech generator
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Provide a unique response to a question like "What is the weather like outside?"
Respond to an assessment
Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty"
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution
- 00186648000531 ()
10000028
- Assistive speech generator
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments
The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partialhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=536963#ly or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap.
The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 5824T(II)
Not in Commercial Distribution
- 08806195923108 ()
- Ø5.8X4.0(2.0)mm
SAC 5824T(II)
- Screw endosteal dental implant, two-piece
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
BioWink GmbH
1
In Commercial Distribution
- 04260749840008 ()
- Self-care monitoring/reporting software
Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930708#reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess.
DENT ZAR, INC.
0055
In Commercial Distribution
- D83600550 ()
0055
- Orthodontic bracket adhesive
Move into multi-message communication with the BIG Step-by-Step speech device. Activate the large colored top to play the first message. When done, activate the top again to play another message. New sequences of messages are easily and quickly recorded to the BIG Step-by-Step on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Record pages of a book to tell a story
Count from 1 to 10
Ask a series of questions
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the BIG Step-by-Step. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000043
In Commercial Distribution
- 00850011150085 ()
10000043
- Assistive speech generator