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510(k) Data Aggregation
K Number
K232441Device Name
Unipro (K-UNIPRO-US)
Manufacturer
TensCare Ltd
Date Cleared
2024-08-30
(382 days)
Product Code
GZJ, IPF, LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TensCare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:
- · Relaxation of muscle spasm
- · Increasing local blood circulation and muscle re-education
- · Prevention or retardation of disuse atrophy
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
- · Maintaining on increasing range of motion
MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.
Device Description
Unipro is a non-invasive, non-sterile, reusable medical device which is intended to be used in both the hospital and home healthcare environment. It is a microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator which is powered by a built in Li-ion rechargeable battery.
Unipro is a multitherapy unit that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), MIC (Microcurrent Stimulation) and IFT (Interferential Therapy). The mode selection button on device will enable the user to switch between different modes (TENS, EMS II, EMS III, or massage). Each time the user changes the mode or program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.
Unipro Case L (large) features a white ABS case with a white silicone button pad and white power button. Power button is located on the right-hand side of the device. The hardware features a black perimeter border and black LCD display. Charging cable and lead inserts are located on the bottom of the device.
Unipro is supplied with self-adhesive electrodes which attach to the control unit via lead wires. A gentle electrical current is sent to underlying nerves and muscle groups via these electrodes applied on the skin to relieve pain. Placement of the electrode pads of the device depends on the selected device mode (TENS, EMS, IFT2, IFT4, MIC). For TENS, the easiest way is to apply the electrode pads around/near the source of the pain. For EMS, place two electrode pads over the bulk of the muscle, with one electrode over the muscle's motor point. For IFT2, electrodes should be placed either side of the area of pain and for IFT4, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. Finally, for MIC, the electrode pads should be placed in such a way that a straight line between them passes through the problem area.
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K Number
K230926Device Name
Ova+ (K-OVAP-USA)
Manufacturer
TensCare Ltd
Date Cleared
2023-12-15
(256 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TensCare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
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.
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K Number
K230983Device Name
Unicare (K-UNICARE-USA)
Manufacturer
TensCare Ltd
Date Cleared
2023-10-20
(197 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
TensCare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Unicare 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, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Device Description
Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.
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K Number
K231053Device Name
Unicare (K-UNICARE-USA)
Manufacturer
TensCare Ltd
Date Cleared
2023-08-18
(127 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TensCare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K200694Device Name
Perfect EMS
Manufacturer
TensCare Ltd.
Date Cleared
2021-06-04
(444 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TensCare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
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, pushbutton 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.
Accessories: 2 x 1.25m PVC Lead Wires (L-CPT) 50x50mm hydrogel electrode pads (E-CM5050)
Optional accessories: 50x100mm Large hydrogel electrode pads Pack of 4 (E-CM50100)
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K Number
K191312Device Name
Perfect PFE
Manufacturer
TensCare Ltd.
Date Cleared
2019-11-01
(170 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
TensCare Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Perfect PFE 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, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Device Description
The Perfect PFE is a hand-held, home-use device designed to treat stress, urge and mixed urinary continence in women and maintain urinary continence in women. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe. The probe connects to the control unit by cable and plug and is inserted into the end user. The probe has a recommended usage duration of 6 months.
The device is battery powered, single channel, home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. 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. It has four preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.
Accessories: Lead Wire (L-CPT) Liberty Loop vaginal probe (X-VPL)
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K Number
K142506Device Name
TensCare KegelFit
Manufacturer
TENSCARE LTD.
Date Cleared
2015-04-20
(224 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
TENSCARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.
Device Description
The KegelFit is a hand-held, home-use device designed to treat female stress urinary incontinence. The device is supplied with a vaginal two electrode stimulation probe (Trainer). The trainer connects to the control unit by cable and plug and is inserted into the vagina by the end user. Electrical stimulation is delivered via stainless steel electrodes on the trainer to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The device is battery powered single channel home use neuromuscular stimulation. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. 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 two preset treatment programs, a preset treatment timer, a compliance monitor, and open circuit detectors.
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K Number
K103698Device Name
TENSCARE ITOUCH SURE MODEL ITS
Manufacturer
TENSCARE LTD.
Date Cleared
2011-06-21
(183 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
TENSCARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The itouch Sure 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, urge, and mixed urinary incontinence in women
Device Description
The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug. 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 programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.
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K Number
K082377Device Name
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
Manufacturer
TENSCARE LTD
Date Cleared
2009-02-09
(175 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TENSCARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The itouch TENS system is indicated for:
- Symptomatic relief and management of chronic, intractable pain. .
- Adjunctive treatment for post-surgical and post-trauma acute pain. .
Device Description
A portable TENS device for pain relief.
Features:
- Innovative design
- Large LCD display
- Dual output isolated channels
- 2 AA Alkaline Batteries
- Adjustable frequency, pulse width, and timing parameters
- 9 different modes
- Timer option
- Doctor lock/unlock facility
- Open circuit detectors
- Non-volatile
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K Number
K023997Device Name
TENSCARE ULTIMA NMS/EMS
Manufacturer
TENSCARE LTD.
Date Cleared
2003-03-03
(90 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
TENSCARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the TENS function: TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pain.
For the EMS function: The Ultima NMS/EMS is indicated for: Relaxation of muscle spasm. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Prevention of venous thrombosis of the calf. muscles immediately after surgery. Maintaining or increasing range of motion.
Device Description
For the TENS function: A portable TENS device for pain relief.
For the EMS function: A portable EMS device for the re-education of muscles.
The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions.
The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity).
In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices.
The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device.
The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no control over the devices outputs; the Programs are pre-set by the Treating Physician.
The use of 'shrouded patient cable connectors' to comply with FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" is utilised to further ensure no hazards exist.
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