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510(k) Data Aggregation
K Number
K113017Device Name
SYS*STIM 240
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2012-06-26
(259 days)
Product Code
IPF, GZJ, ILY, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms
- Symptomatic relief and management of chronic, intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
3. Indications for DC (Direct Current) Mode
- Relaxation of muscle spasm
4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:
- Temporary increase in local blood circulation
- Temporary relief of minor muscle and joint aches, pains and stiffness
- Relaxation of muscles
- Temporary relief of muscle spasms
- Temporary relief of minor pain and stiffness associated with arthritis
Device Description
The new Sys*Stim® 240 neuromuscular stimulator features nine discrete waveforms designed to facilitate clinical versatility. Waveforms may be combined with on-off programs for neuromuscular education as well as frequency and amplitude modulation programs for optimal pain management.
New touch-sensitive technology has been used to make starting a treatment easy. The high-resolution color display allows clinicians to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.
Clinicians can add full-featured light therapy capabilities to the Sys*Stim 240 by purchasing either the cluster or laser applicator package. The laser applicator has an 80 mW, 785 nm, laser diode and the cluster emits 500 mW at 600 and 950 nm. Applicator holders are provided with each applicator and can be attached to the sides of the Sys*Stim 240.
Treatment protocols complete with electrode placement quidance allow clinicians to quickly program treatment parameters for their patients. There is even space to save special treatment protocols for each waveform and for light therapy.
The Sys*Stim 240 has an optional battery pack so that clinicians can take either electrical stimulation or light therapy to their patients. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road.
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K Number
K111482Device Name
SONICATOR PLUS 920
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2011-08-25
(90 days)
Product Code
IMG, GZI, GZJ, IPF
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. 3. Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness, Capsular tightening.
4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain.
EMS, TENS, Hi Volt and Russian waveforms: 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
DC (Direct Current): 1. Relaxation of muscle spasms.
Device Description
The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available. The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option. The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols. The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.
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K Number
K091540Device Name
MTD 4000
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2009-10-08
(135 days)
Product Code
ITH
Regulation Number
890.5900Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.
The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:
- Protruding discs
- Bulging discs
- Herniated discs
- Degenerative disc disease
- Posterior facet syndrome
- Acute facet problems
- Radicular pain
- Prolapsed discs
- Spinal root impingement
- Hypomobility
- Degenerative joint disease
- Facet syndrome
- Compressions fractures
- Joint pain
- Discogenic pain
Device Description
The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.
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K Number
K071137Device Name
SONICATOR PLUS 940, MODEL ME940
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2007-08-01
(99 days)
Product Code
IMG, GZJ, LIH
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therapeutic Ultrasound:
1. Relief of pain, muscle spasms and joint contractures:
2. Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
3. Relief of pain, muscle spasms and joint contractures resulting from:
- Capsular tightness
- Capsular tightening
4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms:
1. Symptomatic relief of chronic intractable pain
2. Post-traumatic pain
3. Post-surgical pain
EMS, TENS, Hi Volt and Russian waveforms:
1. Relaxation of muscle spasms
2. Increase local blood circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion
6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis
DC (Direct Current):
Relaxation of muscle spasms
Device Description
The Sonicator® Plus 940 , Model ME 940 is a four-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 940 provides premodulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 940 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.
The four-channel Sonicator Plus 940 allows the clinician to utilize up to two different waveforms using four channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and premodulated modes offer frequency modulation as well as a static frequency option.
The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine.
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. A large LCD output display allows the clinician to monitor four channels simultaneously for four channel combination treatment protocols. It also allows the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.
The Sonicator Plus 940 can provide electrical stimulation only. ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms
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K Number
K053546Device Name
SONICATOR 740, MODEL ME 740
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2006-05-04
(135 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultrasound delivered to the body using an efficient couplant provides deep heating effects to body tissues. Ultrasound delivered at a frequency of 1 MHz penetrates to a depth of approximately 5 centimeters while ultrasound at a frequency of 3.3 or 3.2 MHz penetrates tissue to a depth of approximately 1-2 cm.
When therapeutic ultrasound is delivered to the body at intensities capable of generating a deep tissue temperature increase, some or all of the following effects may occur:
- 1. Pain relief
- 2. Reduction of muscle spasm
- 3. Localized increase in blood flow
- 4. Increase range of motion of contracted joints using heat and stretch techniques.
Device Description
Sonicator® 740, Model ME 740
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K Number
K043586Device Name
LASER SYS*STIM 540, MODEL ME 540
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2005-05-06
(129 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Sys*Stim 540, Model ME 540 is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.
Device Description
The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasive, low level infrared lamp that provides continuous and pulsed heat therapy at a fixed frequency. The system consists of a drive unit/power supply that houses the electronics, controls and displays and optional treatment probes that contain the visible and infrared radiating elements.
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K Number
K042554Device Name
AUTO THERM 390, MODEL ME 390
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2004-10-08
(18 days)
Product Code
IMJ
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used for the treatment of many conditions such as:
1. Relieving pain.
2. Reducing muscle spasm.
3. Increasing range of motion of contracted joints using heat and stretch techniques.
4. Increasing blood flow to tissues in the treatment area.
Device Description
The Auto*Therm 390 is a shortwave diathermy device that operates at 27.12 MHz. It provides shortwave diathermy therapy using condenser and electromagnetic inductive coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and medical practice. The ME 390 is portable and easily transportable between treatment rooms. A four-wheel cart is provided when the optional induction electrode and arm are used. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on the top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 390. The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting cables for the condenser and inductive coil applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.
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K Number
K031017Device Name
SYS*STIM 208 AND 208A
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2003-05-30
(60 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions.
6. Muscle re-education.
7. Maintaining or increasing range of motion.
Device Description
Sys*Stim 208, Model ME 208: The microprocessor controlled Sys*Stim 208 produces low volt current through one channel. The unit produces an asymmetrical electrically balanced waveform. There are three modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz and Surge-80 Hz, On/Off times variable. The Sys*Stim 208 is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys*Stim 208 is the Patient Termination Switch, which is connected to the jack located on back of the unit.
Sys*Stim 208A, Model ME 208A: The microprocessor controlled Sys*Stim 208A produces low volt current through two channels. The unit produces an asymmetrical electrically balanced waveform. There are four modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz, Surge-80 Hz, On/Off times variable and Recip-80 Hz, output alternates between the two channels. The Sys*Stim 208A is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys+Stim 208A is the Patient Termination Switch, which is connected to the jack located on back of the unit.
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K Number
K023083Device Name
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2003-02-28
(164 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The one megahertz ultrasound/peristaltic irrigation pump combination system, trade name Silberg T.P.S. (Tissue Preparation System), provides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any life-sustaining purpose.
Device Description
The Silberg Tissue Preparation System, Model ME 800, consists of a 1 MHz ultrasonic generator, 10 cm2 ultrasonic applicator, peristaltic pump irrigation unit. foot switch, hollow cannula, system cart, IV pole with saline solution bag and irrigation tubing set.
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K Number
K022458Device Name
AUTO*THERM 395, MODEL ME 395
Manufacturer
METTLER ELECTRONICS CORP.
Date Cleared
2002-09-26
(62 days)
Product Code
IMJ
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
METTLER ELECTRONICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:
1. Relieving pain;
2. Reducing muscle spasm;
3. Increasing range of motion of contracted joints using heat and stretch techniques; and
4. Increasing blood flow to tissues in the treatment area.
Device Description
The Auto*Therm 395 is a shortwave diathermy device that operates at 27.12 MHz. It provides traditional shortwave diathermy therapy using condenser and electromagnetic coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and the medical practice.
The ME 395 has four wheels for easy transportation between treatment rooms. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 395.
The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting the cables for the condenser and coll applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.
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