FDA.reportPublic FDA data

Tenscare, Ltd.

Matched from indexed company URL: TENSCARE LIMITED

PMN#

GUDID#

TensCare - The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress incontinence in women.The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles.It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises.The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control.Stimulator, Electrical, Non-implantable, for Incontinence –Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPIRegulation Number: 21 CFR 876.5320Regulatory Class: II

TENSCARE LIMITED

2024-11-18

TensCare - Form Duo is a variant of the Perfect EMS medical device and is identical to the Form unit but comes with two stimulators. It has one programme identical to one programme on the Perfect EMS.Form is an innovative electrical muscle stimulator used to target muscles for local and wholebody muscle recovery. The stimulator delivers small electrical impulses via smart, body-worn electrodes, designed to optimise muscle coverage, motor point activation and elicit small muscle contractions. This type of ‘active recovery’ helps the muscle recovery process without causing cardiovascular fatigue. Enhance your recovery routine and return to activity faster with Form.

TENSCARE LIMITED

2024-07-25

TensCare - The Ova3 is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle. The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves. The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova3 is easily controlled by the end user using manual, push-button controls.The new device Ova3 uses the same technical principle and substantially equivalent stimulation parameters to predicate devices marketed Livia (K183110) and/or Perfect EMS (K200694)The Ova3 uses a rechargeable Li-Ion polymer battery and a custom TENS. The Ova3 is supplied with adhesive electrode gel pads.

TENSCARE LIMITED

2024-07-24

TensCare - The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle. The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves. The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova+ is easily controlled by the end user using manual, push-button controls.The new device Ova+ uses the same technical principle and substantially equivalent stimulation parameters to the marketed device Livia (K183110) and/or reference predicate device Perfect EMS (K200694)The Ova+ uses a rechargeable Li-Ion polymer battery and a custom TENS connecting lead with 2mm connecting pins. The Ova+ is supplied with adhesive electrodes that are similar to those of the predicate devices.

TENSCARE LIMITED

2024-01-16

TensCare - Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one unit. It sends a small and gentle stimulation (similar to your natural nerve impulses) to the muscles being treated via two or four auto-adhesive electrode pads, in order to help you to firm and tone your body.Unifit is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Unifit is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has preset treatment programs and manually adjustable programmes are available.

TENSCARE LIMITED

2023-11-03

TensCare - The Unicare is a powered muscle stimulator used for strengthening the pelvic floor muscles.It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Unicare can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. Additionally, the Unicare offers drug-free relief from period pain.

TENSCARE LIMITED

2023-10-24

TensCare - Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the therapeutic head, the impact energy is converted into a radial ballistic shock wave pulse, which is focussed to create the characteristics required to have a good therapeutic effect for musculoskeletal disorders.The innovative technology has a compact design with no need for a compressor. The clear colour display shows all relevant treatment parameters and offers touch screen operation for ease of use during treatment.Variable frequencies and various applicator heads allow treatment to be adapted to the particular condition of the patient.

TENSCARE LIMITED

2023-06-08

TensCare - The iTouch Sure 2 is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal probe with stainless steel electrodes. These signals make your pelvic floor muscles contract. If you have forgotten how to contract them, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the itouch sure can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The itouch sure is very easy to use, with four clearly labelled preset training programmes and a simple push button control.

TENSCARE LIMITED

2023-08-31

TensCare - Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Sports TENS 2 is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has fifty preset treatment programs and four manually adjustable programmes are available.

TENSCARE LIMITED

2023-08-31

TensCare - Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has six preset treatment programs and four manually adjustable programmes are available.

TENSCARE LIMITED

2023-08-31

TensCare - Form is a variant of the Perfect EMS medical device. It has one programme identical to one programme on the Perfect EMS.Form is an innovative electrical muscle stimulator used to target muscles for local and wholebody muscle recovery. The stimulator delivers small electrical impulses via smart, body-worn electrodes, designed to optimise muscle coverage, motor point activation and elicit small muscle contractions. This type of ‘active recovery’ helps the muscle recovery process without causing cardiovascular fatigue. Enhance your recovery routine and return to activity faster with Form.

TENSCARE LIMITED

2023-06-28

TensCare - Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the therapeutic head, the impact energy is converted into a radial ballistic shock wave pulse, which is focussed to create the characteristics required to have a good therapeutic effect for musculoskeletal disorders. The innovative technology has a compact design with no need for a compressor. The clear colour display shows all relevant treatment parameters and offers touch screen operation for ease of use during treatment. Variable frequencies and various applicator heads allow treatment to be adapted to the particular condition of the patient.

TENSCARE LIMITED

2023-06-08

TensCare - Sports TENS 2 is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Sports TENS 2 is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles.The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has fifty preset treatment programs and four manually adjustable programmes are available.

TENSCARE LIMITED

2022-03-01

Tenscare - TENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lowerback, arms, or legs due to strain from exercise or normal household and work activities.It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.

TENSCARE LIMITED

2019-08-05

Pain Aide - Pain Aide is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.It has four preset programs specially designed to alleviate pain in different parts of the body. Pain Aide is designed to be easy to use, but has professional grade features like small 1 mA intensity steps, open-circuit detection with cutout, automatic keypad locking, and back-lit display. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.

TENSCARE LIMITED

2018-11-12

42 records. Showing 1-40. Next