(562 days)
Not Found
No
The description focuses on standard therapeutic ultrasound and neuromuscular stimulation functionalities controlled by a microprocessor and user interface, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive treatment.
Yes
The device is described as a "Therapeutic Ultrasound" and "Neuromuscular Stimulation" unit with indications for pain relief, muscle spasm reduction, increased blood flow, and increased range of motion, which are all therapeutic benefits.
No.
The "Intended Use / Indications for Use" section lists pain relief, reduction of muscle spasm, increase of blood flow, prevention of phlebo-thrombosis, prevention of disuse atrophy, muscle re-education, and maintaining or increasing range of motion. These are all therapeutic applications, not diagnostic ones. The device description also confirms it is a combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy.
No
The device description clearly outlines multiple hardware components including a system console, control electrodes, a control and display panel, a specially designed cart, and a power supply. It also describes the device as a "two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy." This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications are all related to therapeutic treatment of the body (pain relief, muscle spasm reduction, blood flow increase, range of motion improvement, etc.) using physical modalities (ultrasound and neuromuscular stimulation). These are not diagnostic purposes.
- Device Description: The description details a device that delivers therapeutic ultrasound and electrical stimulation. It does not mention any components or functions related to analyzing samples from the human body (like blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as sample types, reagents, analytical methods, or diagnostic results.
In summary, the BRH-A2 CUSEFS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is intended for ultrasound and neuromuscular stimulation
Therapeutic Ultrasound:
- Pain relief
- Reduction of muscle spasm
- Localized increase of blood flow
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
- Temporary relaxation of muscle spasm
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Increase of blood flow in the treatment area.
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Muscle re-education
- Maintaining or increasing range of motion
TARGET POPULATION
Adult patients
Product codes (comma separated list FDA assigned to the subject device)
IMI, IMG, IPF, LIH
Device Description
The BRH-A2 CUSEFS is comprised of the following main components:
- A system console including software and control electrodes;
- A control and display panel
- Specially designed cart
- User-friendly touch screen
. The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.
The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.
There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Physical therapy clinics; hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing:
Testing information demonstrating performance of BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) device in the intended environment of use is supported by testing that was conducted in accordance with FDA recognized standards as follows:
The following testing was conducted to prove safety and effectiveness as well as Substantial equivalence to the predicate devices:
| Item | Test Name | Results |
|---|---|---|
| 1 | ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) "Medical electrical equipment. Part 1: General requirements for safety and essential performance" | Passed all testing requirements |
| 2 | IEC 60601-2-5:2009 Medical electrical equipment. Part 2-5: Particular requirements for the safety of ultrasonic-physiotherapy equipment" | Passed all testing requirements |
| 3 | IEC 60601-2-10 Edition 2.0 2012-06 “Medical electrical equipment. Part 2- 10 Particular requirements for the safety and essential performance of nerve and muscle stimulators. | Passed all testing requirements |
| 4 | ISO 14971:2007 "Medical devices – Application of risk management to medical devices” including residual risks evaluation. | Passed all testing requirements |
| 5 | IEC 60601-1-6 Edition 3.1 2013-10 "Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability" | Passed all testing requirements |
| 6 | IEC 60601-1-8:2006 & A1:2012 "Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance– Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems" | Passed all testing requirements |
| 7 | IEC 60601-1-2: 2007 /AC: 2010 “Medical electrical equipment. Part 1-2: Electromagnetic compatibility – Requirements and tests" | Passed all testing requirements |
| 8 | IEC 62304 Edition 1.1 2015-06 "Medical Device Software Development" | Passed all testing requirements |
| 9 | ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes | Passed all testing requirements |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
BRH Medical Ltd. % Susan D. Goldstein-Falk Vice President - FDA Compliance mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck. New York 11021
Re: K160378
Trade/Device Name: BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI, IPF, LIH, IMG Dated: July 27, 2017 Received: July 28, 2017
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160378
Device Name
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
Indications for Use (Describe)
Therapeutic Ultrasound:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase of blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions
-
- Muscle re-education
-
- Maintaining or increasing range of motion
TARGET POPULATION Adult patients
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for BRK Medical. The logo features the letters "BR" in gray, with the letter "K" stylized as a teal human figure with outstretched arms. Below the letters "BR" is the word "medical" in teal, written in a smaller, sans-serif font. The overall design is clean and modern, suggesting a company focused on health and well-being.
K160378 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
General Information:
| Applicant: | BRH Medical Ltd. The Jerusalem Technological Gardens Building A, 1st Floor Jerusalem, 96951, Israel Tel: + 02-6483519 |
|---|---|
| Contact Persons: | |
| CEO | Motti Oderberg Tel: ++ 972 (0)54-6772277 E-mail: Motti@026430010.co.il |
| СТО | ILAN Feferberg Tel: ++972 (0)54-6678330 E-mail: imft@zahav.net.il |
| Date Prepared: | August 24, 2017 |
| Device Trade Name: | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) |
| Common or Usual Name: | Ultrasonic diathermy for Use in Applying Therapeutic Deep Heat |
| Classification Name: | Ultrasonic Diathermy (21 CFR 890.5300) |
| Regulatory Class: | Class II |
| Product Code: | IMI |
| Common or Usual Name: | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Classification Name: | Ultrasound and muscle stimulator (21 CFR 890.5860) |
| Regulatory Class: | Class II |
| Product Code: | IMG |
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Image /page/4/Picture/0 description: The image shows a logo for BRK medical. The letters "BR" are in gray, and the letter "K" is stylized in blue with a figure of a person with their arms raised above their head. The word "medical" is written in blue below the letters "BR".
Common or Usual Name: Classification Name: Regulatory Class: Product Code:
Common or Usual Name: Classification Name:
Regulatory Class: Product Code:
The Jerusalem Technological Garden Building A' Floor 1 Jerusalem -96591- Israel Tel ++972-2-6483519 Fax ++972-2-6483541
Stimulator, Muscle, Powered Powered muscle stimulator (21 CFR 890.5850) Class II IPF
Interferential Current Therapy Transcutaneous electrical nerve stimulator for pain relief (21 CFR 882.5890) Class II LIH
5
Image /page/5/Picture/0 description: The image contains a logo for BRK medical. The letters 'BR' are in gray, with 'K' in teal and a stick figure with arms raised incorporated into the 'K'. Below the letters is the word 'medical' in teal. The logo is simple and modern, using a clean font and a limited color palette.
| Primary Predicate Device: | Trade Name Sonicator® Plus 930
(Combination ultrasound and muscle stimulator) Mettler Electronic
Corp.
K013192 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate Device: | Trade Name The DU857 Dual Frequency Ultrasound Therapy
and Muscle Stimulator System
Alfa Tech Medical Systems Ltd.
K052340 |
Device Description:
The BRH-A2 CUSEFS is comprised of the following main components:
- A system console including software and control electrodes; ●
- A control and display panel
- Specially designed cart
- User-friendly touch screen
- . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.
The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.
There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.
6
Image /page/6/Picture/0 description: The image shows the logo for BRK medical. The letters "BR" are in gray, with the "R" slightly overlapping the "B". To the right of the letters is a stylized figure of a person in teal. The word "medical" is in teal below the letters "BR".
Indications for Use:
The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is intended for ultrasound and neuromuscular stimulation
Therapeutic Ultrasound:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase of blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions
-
- Muscle re-education
-
- Maintaining or increasing range of motion
TARGET POPULATION
Adult patients
7
Image /page/7/Picture/0 description: The image contains the logo for BRK medical. The logo has the letters "BR" in gray, with the letter "K" in teal. The "K" is stylized to look like a person with their arms raised. Below the letters is the word "medical" in teal.
Substantial Equivalence Comparison of Subject Device to Predicate Devices
| Parameter | BRH-A2 Combined Ultrasound
and Electric Field Stimulation
(CUSEFS) K160378 | Primary Predicate
Sonicator Plus 930
K013192 | Secondary Predicate
DU857 K052340 |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | BRH-A2 Combined Ultrasound and
Electric Field Stimulation (CUSEFS) | Sonicator Plus 930 | DU857 |
| 510(k) number | K160378 | K013192 | K052340 |
| Classification
Name | Ultrasonic Diathermy for Use in
Applying Therapeutic Deep Heat,
Stimulator, Ultrasound And
Muscle, For Use In Applying
Therapeutic Deep Heat,
Stimulator, Muscle, Powered and
Interferential Current Therapy | Ultrasonic Diathermy,
Powered Muscle
Stimulator, Transcutaneous
Electrical Nerve Stimulator
for Pain relief and
Interferential Current
Therapy. | Ultrasound and Muscle
Stimulator |
| Model Number | BRH-A2 | ME930 | DU857 |
| Product Code | IMI, IMG, IPF, LIH | IMI, GZJ, IPF, LIH | IMI, IMG, IPF, LIH |
| Manufacturer | BRH Medical Ltd. | Mettler Electronics | Alfa Tech Medical
Systems Ltd |
| Indications for
use | Therapeutic Ultrasound:
- Pain relief
- Reduction of muscle
spasm - Localized increase of
blood flow - Increase range of motion
of contracted joints using
heat and stretch
techniques.
Neuromuscular Stimulation
- Symptomatic relief of
chronic intractable pain,
acute post traumatic pain
or acute surgical pain - Temporary relaxation of
muscle spasm - Prevention of post-
surgical phlebo-
thrombosis through
immediate stimulation of
calf muscles
Increase of blood flow in - | Therapeutic Ultrasound:
- Pain relief
- Reduction of
muscle spasm - Localized increase
of blood flow - Increase range of
motion of
contracted joints
using heat and
stretch
techniques.
Neuromuscular Stimulation
- Symptomatic relief
of chronic
intractable pain,
acute post
traumatic pain or
acute surgical pain
(Interferential and
Pre-modulated
waveforms) - Temporary | Therapeutic Ultrasound:
- Pain relief
- Reduction of
muscle spasm - Localized
increase of
blood flow - Increase range
of motion of
contracted
joints using
heat and
stretch
techniques.
Neuromuscular
Stimulation
- Symptomatic
relief of chronic
intractable
pain, acute
post traumatic
pain or acute
surgical pain |
| | the treatment area. - Prevention or retardation
of disuse atrophy in post-
injury type conditions - Muscle re-education
- Maintaining or increasing
range of motion
TARGET POPULATION | relaxation of
muscle spasm(all
waveforms)
3. Prevention of
post-surgical
phlebo-thrombosis
through
immediate
stimulation of calf
muscles(all
waveforms)
4. Increase of blood
flow in the
treatment area(all
waveforms)
5. Prevention or
retardation of
disuse atrophy in
post-injury type
conditions(all
waveforms)
6. Muscle re-
education(all
waveforms)
7. Maintaining or
increasing range of
motion(all
waveforms) | 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 |
| | Adult patients | | |
| Design and
Appearance | Image: BRH MEDICAL device | Image: Device with buttons and screen | |
| Size (HxWxD) | 22 x 16.5 x 12 in | 6 x 12 x 12 in | 67 X 26 X 35 in |
| Weight | 22 pounds | 10 pounds | 165 pounds |
| Design | The concept is to combine two
kinds of therapeutic methods in a | The concept is to combine
two kinds of therapeutic | The concept is to
combine two kinds of |
| | compact unit. | methods in one device | therapeutic methods in one device |
| Overall design
difference | Separate touch screen controls
both ultrasound & neuromuscular
stimulation | A membrane panel and a
touch screen to set up
treatments | A membrane panel and
a touch screen to set up
treatments |
| Materials | Metal enclosure | Metal enclosure | Metal enclosure |
| Housing
materials | Folded into a box shape and
seams welded & ground flush and
a stylized ABS cover screwed onto
metal box | Folded into a box shape
and seams welded &
ground flush and a stylized
ABS cover screwed onto
metal box | Aluminum chassis |
| Performance | Use friendly interface, easy to
operate | Use friendly interface, easy
to operate | Use friendly interface,
easy to operate |
| Target
population | Adult patients | Patients who need
Therapeutic Ultrasound and
or Electrotherapy
treatments | Patients who need
physiotherapy
treatment |
| Environment(s)
of use | Physical therapy clinics; hospitals | Physical therapy clinics;
hospitals | Physical therapy clinics;
hospitals |
| BASIC UNIT CHARACTERISTICS | | | |
| Power source | AC Line | AC Line | AC Line |
| Power input | 90-264 VAC, 50-60 Hz | 90-240VAC, 50-60Hz | 90-132VAC, 50-60Hz,4A;
207-264VAC, 50Hz, 2A |
| Method Line
current isolation | Yes
Isolation transformer | Yes | Yes |
| Operating
temperature | +50°F to +104°F | +50°F to +104°F | +50°F to +86°F |
| Humidity | Operating, 30% to 75% RH (not
condensed)
Storage, 20% to 80% RH (not
condensed) | Operating, 30% to 75%
Relative Humidity (RH) at
104°F
Storage, 5% to 95% RH (not
condensed) | Operating, 30% to 75%
Relative Humidity at
86°F
Non operating, 20 to
80% Relative Humidity,
noncondensing |
| Storage
temperature | 40°F to 167°F | 40°F to 167°F | 32°F to 113°F
0°C to 45°C |
| Indicator display | Yes | Yes | Yes |
| On/off status | | | |
| Treatment
timer | Treatment time counts down to
zero when time is set | Treatment time counts
down to zero when time is
set | Treatment time counts
down to zero when a
time is set, or up to 30
minutes when no time is
set. The digital timer
indicates the remaining
or elapsed treatment
time during the "Hold" |
| Timer Accuracy | | | |
| | ± 0.5 seconds for all times range | ±0.5 minutes for times less
than 5 minutes
tl 0% for times from 5 to 10
minutes
±1.0 minute for times
greater than 10 minutes | ± 5 seconds for all times
range |
| Number of channels | 2 | 2 | 2 |
| Software control | Yes | Yes | Yes |
| Automatic overload trip | Yes | Yes | Yes |
| Insulation | BF | BF | BF |
| Patient override control | Yes | Yes | Yes |
| Maximum Treatment Time | 30 minutes - ultrasound therapy
30 minutes - neuromuscular
stimulation | 30 minutes - ultrasound
therapy
60 minutes -
neuromuscular stimulation | 30 minutes - ultrasound
therapy
30 minutes - neuro
muscular stimulation |
| Treatment Timer | Treatment time counts down to
zero when time is set, or up to 30
minutes when no time is set. The
digital timer indicates the
remaining or elapsed treatment
time during the 'Hold' period. | Treatment time counts
down to zero when time is
set, or up to 60 or 30
minutes when no time is
set. The digital timer
indicates the remaining or
elapsed treatment time
during the 'Hold' period | Treatment time counts
down to zero when time
is set, or up to 60 or 30
minutes when no time is
set. The digital timer
indicates the remaining
or elapsed treatment
time during the 'Hold'
period |
| Power Indicator | Yes | Yes | Yes |
| Operational Indicator | Yes | Yes | Yes |
| THERAPEUTIC ULTRASOUND | | | |
| Transducer | 4 cm2 transducer | 5 cm2 transducer | 5 cm2 transducer |
| Frequencies | 1.0 MHz ± 5% to 3.0 MHz ± 5% | 1.0 MHz ± 5% to 3.0 MHz ±
5% | 1.0 MHz ± 5% to 3.0
MHz ± 5% |
| Modes | Continuous | Continuous
Pulsed - 20% duty cycle
Pulsed - 50% duty cycle | Continuous |
| Pulse repetition rate | Not applicable | 100 Hz ± 20% | Unknown |
| Pulse duration | Not applicable | 2 msec±20%, 20% duty
cycle | Unknown |
| Temporal peak /
average
intensity ratio | Not applicable | 5:1±20%, 20% duty cycle | Unknown |
| Maximum | 8 W with at 4 cm2 applicator | 11 W with a5 cm2 | 7W with a5 cm2 |
| output power | (Ma-11cb) | applicator, (ME 1513) | applicator, |
| Maximum intensity | $2.0 W/cm^2$ | $2.2 W/cm^2$ | $1.5 W/cm^2$ |
| Indication Accuracy | ±20% (for any level above 10% of maximum) | ±20% (for any level above 10% of maximum) | ±20% (for any level above 10% of maximum) |
| Fixed treatment head placement | Not Applicable | Not Applicable | Unknown |
| Treatment head weight | 0.250 KG | Unknown | Unknown |
| Leakage current | $0.003 \mu A$ | Unknown | Unknown |
| Crystal material | PZT807 | Unknown | Unknown |
| Technology of ultrasound generation (e.g., piezoelectric, magnetostrictive) | Piezoelectric | Piezoelectric | Piezoelectric |
| Beam maximum intensity and accuracy (W/cm2) | 2 W/cm2±5% | Unknown | Unknown |
| THERAPEUTIC ULTRASONIC APPLICATOR SPECIFICATIONS | | | |
| Applicator Part Number | Ma-11cb | ME7513 | |
| Treatment head dimensions | D4.5x 15.5cm | D5.5x 17cm | Unknown |
| Transducer contact face Biological evaluation | 303 stainless steel | 303 stainless steel | The output transducer utilizes a barium titanate disc with a specially coated face |
| Contact Monitor | Light on transducer | Light on transducer | Light on transducer |
| Frequency | 1.0 MHz ± 5% to 3.0 MHz ± 5% | 1.0 MHz ± 5% to 3.0 MHz ± 5% | 1.0 MHz ± 5% to 3.0 MHz ± 5% |
| Beam type | Collimated | Collimated or divergent | Collimated |
| Effective Radiating Area ERA | $4 cm^2$ ±10% | $5 cm^2$ ±10% | $5 cm^2$ ±10% |
| Maximum Beam Non Uniformity Ratio BNR | NEUROMUSCULAR STIMULATION | | | |
| Output
waveforms | Interferential
Not applicable
Not applicable | Interferential
Medium Frequency
Biphasic | Interferential |
| Treatment
timer | 1-30 minutes±1% | 1-60 minutes±1% | 1-30 minutes±1% |
| Automatic shut
off | Yes | Yes | Yes |
| Current level
indicator display | Yes | Yes | Yes |
| Number of
output modes | 1 | 3 | 1 |
| Channel(s) | 2 | 2 | 2 |
| Synchronous or
alternating
output channels | Synchronous | Synchronous | Synchronous |
| Max Output
Current (mA) | Interferential
0-65±10% mA RMS, max
$500\Omega$ - 65mA
$2K\Omega$ - 27mA | Interferential
0-65±10% mA RMS, max
1Kohm load | Interferential
0-35±10% mA RMS, max
1Kohm load |
| | N/A | Premodulated and medium
frequency modes
0-50±10% mA RMS, max
1Kohm load | |
| | N/A | Biphasic mode
0-99±10% mA peak, max
1Kohm load | |
| | N/A | High volt mode
0-2500±10% mA peak, max
1Kohm load | |
| | N/A | Microamp mode
10-990±10 μA peak, 1Kohm
load | |
| Max output
Voltage (V) | Interferential
0-65v ±10% volts RMS
500Ω - 42.6V
2KΩ - 56V
10KΩ - 14.8V | Interferential
0-65±10% volts RMS,
1Kohm load
Premodulated and medium
frequency modes
0-50±10% volts
RMS,1Kohm load
Biphasic mode
99±10% volts peak, 1Kohm
load
High volt mode
0-500±10% volts
peak,1Kohm load
Microamp mode
1.0±10% volt peak, 1Kohm
load | Interferential
0-36±30% volts RMS,
1Kohm load |
| Regulated
current or
regulated
voltage | Regulated current | Regulated current | Regulated current |
| Electrode size | Round, 2 inch diameter | Round, 1.5, 2, and 3 inch
diameter | Round 2 inch diameter |
| Maximum
current density
(2 inch dia) | 3.2 mA/cm² at 500Ω
3.2 mA/cm² at 1kΩ
1.33 mA/cm² at 2kΩ
0.08 mA/cm² at 10kΩ | Unknown
3.2 mA/cm² at 1kΩ
Unknown
Unknown | Unknown
Unknown
Unknown
Unknown |
| Maximum
power density | 0.195 W/cm2 at 500kΩ ≤ 0.25
W/cm²
0.208 W/cm² at 1kΩ ≤ 0.25
W/cm²
0.074 W/cm2 at 2kΩ ≤ 0.25
W/cm²
0.0012 W/cm2 at 10kΩ ≤ 0.25
W/cm² | Unknown
0.208 W/cm² at 1kΩ ≤ 0.25
W/cm²
Unknown | Unknown
Unknown
Unknown |
| Compliance
with 21 CFR 898 | Yes | Yes | Yes |
| Electrode
Housing
materials and
construction | No | No | No |
| Carrier
frequency | 4000 Hz | 4000 Hz | 4800 Hz |
| Interferential
Frequency
range | Channel 1=4000Hz
Channel 2=4000 Hz to 4250 Hz ±1%
(Interferential mode) | Channel 1=4000Hz
Channel 2=4000 Hz to 4250 Hz ±1%
(Interferential mode) | Channel 1=4800Hz
Channel 2=4800Hz to 5050 Hz ±1%
(Interferential mode) |
| Interferential
beat frequency
PPS | 1-250 Hz in 5Hz increments | 1-250 Hz depending on
selected program | 1-250 Hz depending on
selected program |
| All Channels | Interferential
N/A
N/A | Interferential
Medium Frequency
Biphasic | Interferential |
| Output Displays | Two simultaneously, amber
channel active indicators | Two simultaneously, amber
channel active indicators | Two simultaneously,
amber channel active
indicators |
| Channel
Isolation | Yes
Transformer isolated | Yes | Yes |
| Automatic No
Load Trip | Yes | Yes | Yes |
| Control Method | On/Off | On/Off or hold | On/Off or hold |
| Max Leakage
Current (μA) | Chassis