(519 days)
Not Found
No
The description mentions a microprocessor controlling parameters and user-savable settings, which are standard features of modern medical devices and do not indicate AI/ML. There is no mention of learning, adaptation, or data-driven decision making beyond pre-programmed variations.
Yes.
The device's intended uses, such as "relaxation of muscle spasms" and "prevention or retardation of disuse atrophy," are therapeutic in nature. The device description as an "electrostimulator" further supports its role in treating medical conditions.
No
The device is described as an electrostimulator intended to contract muscles for therapeutic purposes, such as relaxation of muscle spasms or prevention of disuse atrophy. It does not mention any function for diagnosing conditions.
No
The device description clearly outlines a hardware device with physical components like output channels, a microprocessor, an LCD screen, and encoders for user interaction. It is an electrostimulator, which is a physical device that delivers electrical currents.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies electrical currents to the body for therapeutic purposes (muscle stimulation). This is a therapeutic device, not a diagnostic one.
- Definition of IVD: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such examinations.
- Device Description: The description details an electrostimulator, which is consistent with a therapeutic device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, based on the provided text, the ELECTROMEDICARIN 900 is a therapeutic electrostimulator and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is an electrically powered device intended for medical purposes to repeatdly contracts muscles by passing electrical currents through electrodes contacting the affected area (21 CFR 890.5850) for the following indications for use: relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaning or increasing range of motion
Product codes
IPF
Device Description
The Unit ELECTROMEDICARIN 900 is a 3-channel electrostimulator of low and medium frequency currents.
The 3 output channels makes possible to treat 3 patients at the same time or synchronize several muscle groups. The unit is controlled by a microprocessor which allows a wide variation of parameters in order to work with the optimal currents all the time and for each patient: pulse width, bursts, relaxation time, time of increasing and decreasing ramps, modulation frequency, vector type, ... See all types of waveforms in "Technical Characteristics".
Also, the user can save his/her own parameters in non-volatile memory.
The unit has a 320x240 pixels monochrome (white and blue) LCD of 9" and the Menu options and intensity are selected by means of endless encoders. The end of the treatment is notified with a melody or a sequence of beeps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
K 020478
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: Electromedicarin, S.A.
- 2-Address: Poligono Industrial "Can Volart" C/Torre de Cellers, 6 - 08150 Partes del Vallés Barcelona / Spain +34 / 93 573 07 24 / 86 / 91 3-Phone: 4-Fax: +34 / 93 573 03 31
5-Contact Person: Mr Rafael Barba Trujillo (General Manager)
6-Date summary prepared: February 10th, 2003
7- Official Correspondent: Mansour Consulting
- 8- Address: 1308 Morningside Park Dr
- Alpharetta, GA 30022 USA
9- Phone:
-
(678) 908-8180 (425) 795-9341
10- Fax: -
10- Fax:
12-Device Trade or Proprietary Name: ELECTROMEDICARIN 900
13-Device Common or usual name: Electrostimulator
14-Device Classification Name: Stimulator, Muscle, Powered
15-Substantial Equivalency is claimed against the following device:
Rich-Mar Corporation's Winner ST4 Stimulator, 510k #K000808 (refer to Appendix 2 for FDA website printout) This notification for ELECTROMEDICARIN 900 is of the
ABBREVIATED type as per the declaration of conformity included
in this summary
16-Description of the Device:
The Unit ELECTROMEDICARIN 900 is a 3-channel electrostimulator of low and medium frequency currents.
The 3 output channels makes possible to treat 3 patients at the same time or synchronize several muscle groups. The unit is controlled by a microprocessor which allows a wide variation of parameters in order to work with the optimal currents all the time and for each patient: pulse width, bursts, relaxation time, time of increasing and decreasing ramps, modulation frequency, vector type, ... See all types of waveforms in "Technical Characteristics".
Also, the user can save his/her own parameters in non-volatile memory.
The unit has a 320x240 pixels monochrome (white and blue) LCD of 9" and the Menu options and intensity are selected by means of endless encoders. The end of the treatment is notified with a melody or a sequence of beeps.
17-Intended use of the device: (Indications for use typed on a separate FDA form)
This device is an electrically powered device intended for medical purposes to repeatdly contracts muscles by passing electrical currents through electrodes contacting the affected area (21 CFR 890.5850) for the following indications for use: relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaning or increasing range of motion
18-Safety and effectiveness of the device:
This device is safe and effective as the predicate device Winner ST4 Stimulator.
This is better expressed in the tabulated comparison (Paragraph 19 below)
1
Summary comparing technological characteristics with other predicate devi
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Please find below a tabulated comparison that BLECTROMEDICARIN 900 is substantially equivalent to other medical devices
commercial distribution. Also, Equivalency detailed ch
| FDA file reference number | Basic Unit Characteristics | Output Specifications | ||||
|---|---|---|---|---|---|---|
| Attachments inside notification submission file | 510k 000808 | |||||
| 510k summary print out | Comparison result | Pre-Mod IFC | ||||
| Hi-Volt | ||||||
| Russian | ||||||
| Microcurrent (0.3Hz to 1000Hz) | ||||||
| Similar | PREDICATE DEVICE | Pre-Mod IFC (called Bipolar Interferentials) | ||||
| Hi-Volt (called Rectangular Pulses) | ||||||
| Russian (called MEGAA current) | ||||||
| Microcurrent (1Hz to 200Hz) | ||||||
| TECHNOLOGICAL | ||||||
| CHARACTERISTICS | Characteristic | ELECTROMEDICARIN 900 | ||||
| Indications for use | Identical | Power Sorce | 120VAC / 60Hz | |||
| Target population | Identical | Method of Line Current Isolation | - unknown - | 120VAC / 60Hz | ||
| isolation transformer | ||||||
| Materials | Similar | Patient Leakage Current |
- normal condition
- single fault condition | unknown - | 3
synchronous
isolation transformers |
| Sterility | | Identical | | Software/Microprocessor control | Yes | |
| Biocompatibility | | Identical | | Automatic Overload Trip | Yes | Yes |
| Mechanical safety | | Identical | | Automatic No-Load Trip | Yes | Yes |
| Chemical safety | | Identical | | Automatic Shut Off | No | No |
| Anatomical sites | | Identical | | Patient Override Control | No | No |
| Human factors | | Identical | | Indicator Display - On/Off Status
- Voltage/Current level | Yes
Yes
30 | |
| Number of channels | | Similar | | Timer Range | | Yes
Yes
30 |
| | | PREDICATE DEVICE
4 | | Compliance with Voluntary Standards? | - | Yes |
| Output Waveforms | | Similar
PREDICATE DEVICE
Quadpolar IFC | | Compliance with 21CFR 898? | Yes | |
| | | ELECTROMEDICARIN 900
lower metallic chassis with plastic front cover | | Weight | 9 lbs | 12 lbs |
| | | ELECTROMEDICARIN 900
3 | | Dimensions (inches) [W x H x D] | 15" x 5.5" x 9" | 17" x 5.9" x 14.3" |
| | | ELECTROMEDICARIN 900
Quadpolar IFC (called Tetrapolar Interferentials) | | Housing Materials and Construction | metal cabinet with plastic panel | lower metalic chassis with plastic front cover |
| | Similar | PREDICATE DEVICE | | | | |
| | Characteristic | ELECTROMEDICARIN 900 | | | | |
| | Maximum Output Voltage (± 5%)
(for all waveforms) | ± 150V @ 500Ω
± 150V @ 1000Ω | ± 150V @ 500Ω
± 150V @1000Ω | | | |
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| | Maximum Output Current (± 5%)
- pulsed monphasic, biphasic and
sinusoidal | ± 90 mA @ 500Ω
± 90 mA @ 1000Ω | ± 70 mA @ 500Ω
± 70 mA @ 1000Ω |
|-----------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------|-----------------------------------|
| | - exponentials and galvanic | - | - |
| | Pulse Width (μs) | 10 to 500 | 20 to 500 |
| | Frequency (Hz) | 0.3 to 1000 | 1 to 200 |
| | Interferential Beat Frequency (Hz) | unknown | 1 to 250 |
| | Multiphasic Waveforms | Yes | Yes |
| | - symmetrical phases | 1 to 3300 | 5 to 1000 |
| | - phase duration (ms) | 0 (compensated pulse) | 0 (compensated pulse) |
| | - net charge (μC per pulse) | 45 | 45 |
| | maximum phase charge (μC) | 2 | 2 |
| | Maximum current density (mA/cm²) | - | - |
| | Burst Mode | 5 - 10 | 1 to 25 |
| | - ON Time (seconds) | 5 - 10 - 20 - 30 - 50 | 1 to 25 |
| Energy used and/or delivered | - OFF Time (seconds) | Similar (see Output Specifications) | - |
| Compatibility with environment
and other devices | Identical | - | - |
| Where used | Identical | - | - |
| Standards met | Identical | - | - |
| Electrical safety | Identical (IEC 60601-1: Safety of Medical Electrical Equipment) | - | - |
| Thermal safety | Identical (Class I, Type BF units) | - | - |
| | Identical | - | - |
.
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510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS (DETAILED)
Image /page/4/Figure/1 description: This image is a flowchart with several steps. It starts with a question labeled "How Device is Compared to Marketed Device" and proceeds through a series of questions and decision points. The flowchart includes numbered steps from 3 to 11, and it uses "Yes" and "No" answers to guide the flow. The end result is a determination of "Substantially Equivalent" or a return to point A.
-
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*** Dala may be in the 510(k), ether SIO(k)s, the Center's classification files, or the lifes area,
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(10)
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUL 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Mansour Mansour Consulting, LLC Representing Electromedicarin, S.A. 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K020478
Trade/Device Name: Electromedicarin 900 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Codes: IPF Dated: May 28, 2003 Received: June 2, 2003
Dear Mr. Mansour:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if
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Page 2 - Mr. Jay Mansour
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
l. Mark A. Millener
Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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17
510(k) Number (if known): K020478
Device Name: ELECTROMEDICARIN 900
Indications for Use:
This device is an electrically powered device intended for medical purposes to repeatdly contracts muscles by passing electrical currents through electrodes contacting the affected area (21 CFR 890.5850) for the following indications for use: relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaning or increasing range of motion
for Mark N. Millman
(Divisi Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020478
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) =============================================================================================================================================================================
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)