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Found 6 results
510(k) Data Aggregation
K Number
K131291Device Name
TORC BODY
Manufacturer
JOHARI DIGITAL HEALTHCARE, LTD.
Date Cleared
2013-06-14
(39 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
JOHARI DIGITAL HEALTHCARE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TORC BODY is indicated to be used for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, Toning and Firming of buttocks & thighs.
Device Description
TORC BODY is a powered muscle stimulator with two outputs. This battery powered unit is designed for men & women to provide exercise technology. The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise. The TORC BODY stimulator provides selections of different programs for Bottom Thighs muscles (BTS), Abdominal muscles (ABS) & yet customization of stimulation parameters. Four body areas can be treated simultaneously. The electrical muscle stimulator contracts muscles rhythmically to achieve muscle tone and strength. The belts provided with the device are used to place the electrodes in place on the body area to be treated. The lead wires connect the electrodes with the main stimulator unit. The Torc Body muscle stimulator provides comforting and soothing muscle stimulation to achieve the intended use of strengthening, toning and firming of the muscles of abdomen, thighs and buttocks. The user can increase the intensity to get a stronger stimulation and achieve better results. A touch screen LCD user interface simplifies the selection of the programs and displays the selected program, treatment time and other stimulation parameters. Rechargeable batteries power it. The unit can perform anytime & anywhere. Torc Body is suitable for use by all healthy adults. However as with other form of exercise some care is needed when using them.
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K Number
K112351Device Name
ULTRA BEAUTY
Manufacturer
JOHARI DIGITAL HEALTHCARE, LTD.
Date Cleared
2012-03-30
(227 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
JOHARI DIGITAL HEALTHCARE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultra Beauty device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Device Description
Ultra Beauty is a microcurrent device that provides facial stimulation for cosmetic purposes. Ultra Beauty provides a suite of treatment options, combining the different modes and applications from various devices available in the market. The device provides three easy to use pre-programmed modes and the device manual illustrates in detail the suggested treatment protocols for the desired results. The unit features a portable battery powered base module that features a large LCD display and various buttons for easy navigation through the different treatment settings. Ultra Beauty utilizes two different types of probes and to enhance the ease of use and the maneuverability, each probe is attached to the two separate hand pieces. Stimulations generated by the base unit are delivered to the hand pieces through conductive cables.
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K Number
K102190Device Name
WINSTIM
Manufacturer
JOHARI DIGITAL HEALTHCARE, LTD.
Date Cleared
2011-03-17
(226 days)
Product Code
IMG, GZI, GZJ, IPF
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
JOHARI DIGITAL HEALTHCARE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tone-A-Maticis indicated to be used for
L Russian and EMS for:
- . Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- . Increase local blood circulation
- Muscle re-education .
- . Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
TENS for:
ロ
- Symptomatic relief of chronic, intractable pain.
- · Management of pain associated with post-traumatic or post-operative conditions.
Device Description
The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.
The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.
It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.
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K Number
K090052Device Name
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
Manufacturer
JOHARI DIGITAL HEALTHCARE, LTD.
Date Cleared
2009-05-29
(142 days)
Product Code
QJQ, GZJ, JXK
Regulation Number
882.5800Why did this record match?
Applicant Name (Manufacturer) :
JOHARI DIGITAL HEALTHCARE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FM 10/C is indicated to be used for:
- CES for the treatment of insomnia, depression, or anxiety. .
- TNS for Symptomatic relief and management of chronic intractable pain and/or . as an adjunctive treatment in the management of post-traumatic and postsurgical acute pain.
Device Description
FM 10/C is portable Cranial Electrical Nerve Stimulator. FM 10/C combines uniquely two proven therapies CES for the treatment of insomnia, depression, or anxiety and TENS for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain. Thus FM 10/C offers a partnership between Transcutaneous Electrical Nerve Stimulation (TENS) and Cranial Electrotherapy Stimulation (CES). FM 10/C has three modes viz. (i) TENS Burst (ii) TENS Conventional and (iii) CES mode. It provides easy mode selection through slide switch and user can select any one of the available modes through it. TENS and CES modes will not operate simultaneously so, if CES Leads are inserted then TENS modes are automatically blocked for the user and vice versa. TENS mode is programmable and user will have the option to select pulse width and pulse rate using analog pots. In addition treatment time is also selectable using a slide switch options available are 30 minutes or continuous treatment time. FM 10/c is only battery operated, with low battery indication.
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K Number
K062439Device Name
POWERTONE, MODEL PT-11
Manufacturer
JOHARI DIGITAL HEALTHCARE, LTD.
Date Cleared
2007-01-08
(140 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
JOHARI DIGITAL HEALTHCARE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POWERTONE PT-11 is intended to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of a firmer abdomen.
- Strengthening, toning and firming of buttocks & thigh .
Device Description
Powertone is a Muscle stimulator with two different outputs. This battery powered unit is designed for men & women to provide exercise technology anytime-whether relaxing at home or to use as a part of exercise routine . The stimulation is the most comfortable & this technology makes it easier to combine active & passive exercise.
PT-11 stimulator provides selections of different programs through one output to treat Abdominal muscles (ABS) & through two outputs Bottom /Thighs muscles (BTS). Four body areas can be treated. LCD shows the selected program & balance treatment time.
The MKB panel with the LCD simplifies the selections. This unit is ergonomically designed, being portable it is easy and simple to use, yet works as a Clinical model (two output channels) rechargeable batteries power it. The unit can perform anytime & anywhere. Powertone is suitable for use by all healthy adults. However as with other form of exercise, some care is needed when using them. The electrical muscle stimulator (Powertone) contracts muscles rhythmically to achieve muscle tone and strength. This unit contains six self-adhesive electrodes, which can be fixed to the belt with buttons.
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K Number
K024036Device Name
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
Manufacturer
JOHARI DIGITAL HEALTHCARE, LTD.
Date Cleared
2002-12-20
(14 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
JOHARI DIGITAL HEALTHCARE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTENDED USE
- Interferential Current Stimulation is indicated for : A)
- 1. Symptomatic relief and management of chronic and intractable pain.
- Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain 2. conditions.
- B) Electrical Muscle Stimulation (EMS or Russian) is indicated for:
- 1 . Relaxation of Muscle spasm.
- 2. Prevention or Retardation of disuse atrophy.
- 3. Increasing local blood circulation.
- 4. Muscle re-education.
- న్. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- 6. Maintaining or increasing range of motion.
Device Description
Johari 'Combo Stimulator' is a Neuromuscular Electrical Stimulation System, consists of programmable controller just like the predicate device Analgesic Pulsar AP-439. This unit Combo Stimulator allows the treatment specifically tailored to the precise needs of the patient in the clinic and for subsequent treatment off site. The clinicians can set the treatment parameters and lock it, so patient can repeatedly use the unit as prescribed by the clinician. The stimulation is most comfortable and the waveforms are unique.
It has been the clinician requirement many a times where they wanted to have a unit that can perform for muscle stimulation followed by interferential, so that, the painful muscle condition can be treated. Usually they have to turn the machine On and Off for different stimulation waveforms. The unique feature of Combo Stimulator is that in such above conditions, the clinicians can set the unit to perform in such a way that desired muscle stimulation can be followed by desired Interferential stimulation just by pressing one key "Combo", otherwise in itself the unit can perform muscle stimulation through all the outputs or Interferential stimulation through all the output.
The ease and simplicity by which the programming can be done is not more than touch of the key on the panel and LCD display. All the parameters remain in the system control except the amplitude & time which can be set by the patient himself. This unit is ergonomically designed, so that, it is comfortable to hold in hands.
It is portable and has two output channels, four channels works on rechargeable battery system. The unit can perform offsite wherein the hospital room, clinic or home while the predict device Analgesic Pulsar could not run on rechargeable battery system and so limited its use near to the AC outlet. This has always limited the clinicians to perform on their patient. Also many times, the patient may be in need to have a repeated treatment and this modified device "Combo Stimulator" can work in such cases. The Combo Stimulator can provide True Interferential with desired frequency, sweep selection and muscle stimulation of desired mode similar to Analgesic Pulsar.
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