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510(k) Data Aggregation
K Number
K112934Device Name
NEUROTECH RECOVERY
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2012-01-20
(109 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neurotech Recovery is intended for home use. Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.
The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back.
The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.
Device Description
The Neurotech Recovery is a non-sterile, reusable conductive garment for single patient use only. It acts as an interface between the adhesive electrodes on the patient's skin and the Neurotech Plus electrical stimulator which provides Neuromuscular Electrical Stimulation (NMES) or Transcutaneous Electrical Nerve Stimulation (TENS).
The Neurotech Recovery is available as two options, each targeting separate areas of the human anatomy;
- 1. The Neurotech Recovery for the lower back which is constructed of the following materials: Main Panels: 89% Nylon & 11% Spandex laminated to Polyurethane, Silver Trace, Binding: 100% Cotton & Hook and Loop Fastener: 100% Nylon
- 2. The Neurotech Recovery for the abdomen which is constructed of the following materials; Main Panels: 100% Nylon, Binding: 82% Nylon & 18% Elastane, Hook and Loop Fastener: 100% Nylon & Foam Padding: 100% Polyurethane
Included with each Neurotech Recovery conductive garment are conductive gel pads, an extender strap and instructions for use. The device is intended be available by prescription only.
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K Number
K112258Device Name
NEUROTECH PLUS
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2012-01-09
(157 days)
Product Code
GZJ, IPF, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neurotech Plus device is indicated for the following:
In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440:
NMES Indications:
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery
TENS Indications:
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain
Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only)
In Neuromuscular Electrical Stimulation (NMES) only mode, models 437 & 441:
NMES Indications:
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery
In Transcutaneous Electrical Nerve Stimulation (TENS) only mode, model 438:
TENS Indications:
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain
Device Description
The Neurotech Plus is a portable, two-channel; battery operated system which can provide both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The device is intended be available by prescription only. Included with the Neurotech Plus control unit, are a lead wire assembly, electrodes and instructions for use.
The Neurotech Plus contains ten program sets which have been each allocated an individual type number. Seven of these types offer a combination of NMES and TENS programs. There are two types which offer only NMES programs and one which has only TENS programs.
The lead-wire assembly contains the ID chip (EEPROM) that identifies the required program set. Each of the program set options are pre-programmed during manufacturing and no access to the configuration is available to either the end user or clinician. When each lead wire is connected to the unit and the outputs (A, B, C or D) to the electrodes, the two channels may be operated independently through the unit. Detailed diagrams for correct device usage and placement of the electrodes are available as part of the instructions for use.
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K Number
K103031Device Name
BMR FACE
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2011-11-10
(394 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BMR Face is intended for facial stimulation and is indicated for over the counter cosmetic use
Device Description
BMR Face. Type 371/372* (* Type 372 is simply a black version of Type 371) is a twochannel, battery operated cosmetic device which is intended for use on the face. The device consists of a rechargeable electronic device which connects to an applicator. Each side paddle of the applicator contains a set of replaceable twin conductive gel pads which deliver electrical impulses to the face. The BMR Face device operates by applying Transcutaneous Electrical Nerve Stimulation (TENS) to the facial area. Low-level electrical impulses are sent from the stimulator unit via an applicator to gel pads that are positioned anterior to each ear and strategically over the cranial nerve #7 of the face, 3 programs are available to the user and these vary in treatment times from 10 to 20 minutes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit and there is no capability for charging the unit whilst any treatment is ongoing. All internal connections of the unit are over molded to prevent moisture ingress.
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K Number
K110350Device Name
KNEEHAB XP
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2011-08-03
(177 days)
Product Code
GZJ, IPF, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kneehab XP, Type 412/421, Indications for use are as follows:
In NMES mode (Programs 1-6) the Kneehab XP is intended to:
- Maintain or increase the range of motion.
- Prevention or retardation of disuse atrophy
- Re-educate muscles
- Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
- Relax muscle spasms
- Increase blood circulation
In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:
- Provide symptomatic relief and management of chronic, intractable pain
- Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
- Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
- Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee
Device Description
The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.
The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.
All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
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K Number
K102614Device Name
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2011-06-03
(266 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AvivaFix Conductive Garment – Knee, AvivaFix Conductive Garment – Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.
The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee. The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder. The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the shoulder, knee and upper back (cervical) areas.
Device Description
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment -- Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) are intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). The garments aid in the placement of electrodes and secure the electrodes in place. The inner layer of the garment is constructed of Breathoprene", which is a breathable, stretchable fabric developed by AccuMed Technologies as a neoprene substitute to keep skin cooler and drier by wicking away perspiration.
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K Number
K100556Device Name
SLENDERTONE FLEX MAX, MODEL 517 US
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2010-08-02
(154 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Flex Max by Stendertone is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.
Device Description
Flex Max by Slendertone, Type 517-US is a two-channel battery operated muscle stimulation, system specifically designed to exercise the abdominal muscles. It offers 10 programs to the user and comprises of two main components, an electronic stimulator module which generates the required stimulation signals and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The product is supplied with a double set of double-sided adhesive electrodes, a double set of batteries, an extender belt and an instruction manual. Power is derived from 3 x 1.5 volt (LR03) batteries located in a compartment protected by a removable battery cover. Instructions are provided in the user instructions. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
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K Number
K100320Device Name
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2010-05-05
(90 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
Device Description
System Ultra, Type 390, Model E70/X70 is a two-channel, battery powered, muscle stimulation system. It is supplied with a three-electrode abdominal belt garment, a hand-held rechargeable control unit, a pack of 3 adhesive backed gel based electrodes, instructions for use and a carry pouch. The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments. There are ten programs available to users of the System Ultra, Type 390, E70/X70. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit. All the internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path.
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K Number
K092791Device Name
KNEEHAB XP CONTROLLER, MODEL 411
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2009-12-30
(110 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kneehab XP Controller is indicated for muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, prevention or retardation of disuse atrophy in the quadriceps, early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening and increasing local blood circulation.
Device Description
The Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. It is designed to work in conjunction with the Kneehab XP. Conductive Garment and electrodes to deliver highly focused and accurate quadriceps contractions by using constant current pulses to stimulate the nerves in the quadriceps area of the body. The Kneehab XP controller is supplied with a rechargeable control unit, battery charger and instructions for use. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. The controller may be only be connected to the garment/electrodes or the charger due to the utilisation of a single custom connector. All the internal connections of the unit are over-molded to prevent moisture ingress. There are three treatment programs in total with duration of 20 minutes each and details of these are included in the instructions for use.
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K Number
K092793Device Name
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2009-12-07
(87 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neurotech Kneehab Conductive Garment and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the quadriceps area of the leg.
Device Description
The proposed Kneehab XP Conductive Garment is an integrated thigh wrap garment designed to be used in conjunction with a Neurotech stimulator and custom electrodes for the application of neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the thigh. The garment is supplied with a set of four custom designed adhesive pads which may positioned on the inner garment outlines according to fit of the user. Instructions are provided in the user instructions for correct electrode placement. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
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K Number
K083105Device Name
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
Manufacturer
BIO-MEDICAL RESEARCH, LTD.
Date Cleared
2009-07-24
(277 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BIO-MEDICAL RESEARCH, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Muscle re-education of the quadriceps, Maintaining or increase range of motion of the knee joint, Prevention or retardation of disuse atrophy in the quadriceps, Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening, Increasing local blood circulation.
Device Description
The Kneehab XP Conductive Garment is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. This technology enables the Kneehab XP Conductive Garment to deliver highly focused and accurate quadriceps contractions and operates by using constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses are designed to cause muscular contractions through the application of electrical stimulation to the peripheral nervous system. The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device. This device cannot be used while being charged. All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are three treatment programs in total with duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
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