Search Results
Found 7 results
510(k) Data Aggregation
K Number
K111767Device Name
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2011-09-15
(84 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
- Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury
- NeuroMuscular Electrical Stimulation (NMES):
- -Maintenance and/or increase of range of motion
- -Prevention and/or retardation of disuse atrophy
- Increase of local blood circulation -
- Reduction of muscle spasm -
- -Muscle re-education
Device Description
The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device.
Ask a Question
K Number
K080219Device Name
MODIFICATION TO:NESS L300
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2008-02-28
(30 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.
Device Description
This neuroprosthesis device consists of a RF foot sensor (Intelli-sense gait sensor), RF control unit (waist mounted / neck strap / in pocket), and a below the knee orthosis containing electrodes and a RF controlled stimulation unit (RF stim unit).
The Intelli-gait sensor detects "heel off" and "heel contact" events during gait and transmits signals to the RF stim unit. Accordingly, the RF stim unit initiates and pauses the stimulation, activating the foot dorsiflexors to ensure proper foot clearance during the swing phase and proper foot placement during the stance phase.
The NESS L300 comprises of 4 main parts:
1. A lower leg orthosis with integrated RF stim unit and electrodes, RF communication, and rechargeable battery,
2. A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
3. Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
4. Clinician Programmer Handheld computer (PDA)
Ask a Question
K Number
K053468Device Name
NESS L300
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2006-07-07
(206 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase local blood flow.
Device Description
The NESS L300 neuroprosthesis device consisting of a heel sensor, control unit (waist mounted or neck strap or in pocket) and below the knee orthosis containing electrodes and a controlled stimulation unit. The heel sensor detects "heel off" and "heel contact" events during gait. It transmits signals to the stimulator, which initiates/ pauses the stimulation accordingly, thus activating the foot Dorsiflexors to ensure proper foot clearance during the swing phase, and proper foot placement during the stance phase. The NESS L300 comprises of 4 main parts: 1. A lower leg orthosis with integrated stimulation unit (stimulator) and electrodes, RF communication and rechargeable battery. 2. A waist mounted (or in-pocket) control unit (CU), including a PDA interface, RF communication and AAA rechargeable battery. 3. Foot sensor, with RF communication and non-rechargeable coin battery. 4. PDA HP iPAQ hx4700 Pocket PC. The PDA is intended to be used by the clinician for configuring the control unit with the functional parameters as appropriate for every patient.
Ask a Question
K Number
K031900Device Name
HANDMASTER
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2003-08-08
(50 days)
Product Code
GZI, DAT, IPF
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Handmaster is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegic patients due to stroke, it is also intended to provide hand active range of motion and hand function.
Device Description
The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.
The electrode locations allow the Handmaster to give finger and thumb extension and flexion. By pressing the Mode button on the Control Unit, the user can select from seven stimulation programs that comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. In addition to the former light glowing presentation of the active mode, the new LCD screen enables also the presentation of the name of active mode and sub-mode. A continuously changing three and two-bar combination indicates that the stimulation phase is active. A "seventh like" object indicates the stimulation intensity or the battery condition.
The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment like display.
During the initial system set-up, the clinician opens a screw secured clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion.
The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device.
The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal mesh. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge is provided to facilitate wetting of the electrode pads.
Rechargeable nickel-metal-hydride (NiMH) batteries power the device. Battery status can be displayed both during device operation and while recharging the batteries. Both visual and audio battery-low warnings are provided.
Ask a Question
K Number
K024279Device Name
NESS CHILDREN SYSTEM
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2003-02-05
(44 days)
Product Code
IPG
Regulation Number
890.3025Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESS Children System is intended for pediatric use for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.
Device Description
The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.
Ask a Question
K Number
K022776Device Name
NESS SYSTEM
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2002-09-11
(21 days)
Product Code
IPF, IPG
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NESS System is intended to be used for the following indications:
- maintenance or increase of range of motion, ●
- reduction of muscle spasm, ●
- prevention or retardation of disuse atrophy, .
- muscle reeducation, and ●
- increasing local blood circulation. .
Device Description
The NESS System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the thigh, or the leg is provided.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessorcontrolled switching of the stimulation between these electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.
The electrode locations allow the NESS System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.
Ask a Question
K Number
K012823Device Name
MODIFICATION TO HANDMASTER
Manufacturer
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Date Cleared
2001-11-14
(90 days)
Product Code
GZI, IPF
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Handmaster is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.
Device Description
The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the Handmaster to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The active mode is displayed by a light glowing next to the labeled mode. When the device is stimulating, the light flashes. The stimulation programs are supplied as microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment display. During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the with a giobal villing offectively speeding or slowing the cyclic hand motion. The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device. The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the comfortable oncerce and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony with bols poly arounded are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A over and crood bottle is provided to facilitate wetting of the electrode pads. Rechargeable nickel-cadmium batteries power the device. Battery status can be displayed both during device operation and while recharging butteries. Both visual and audio battery-low warnings are provided. It is necessary to disconnect splint/electrodes in order to recharge the batteries, as the same socket is used for both.
Ask a Question
Page 1 of 1