(226 days)
As a TENS device:
Symptomatic relief of chronic (long term) intractable pain
Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
As an Interferential and Premodulated device:
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
As a Russian device:
Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
As an Burst modulated alternaing current (Aussie) device:
Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
As a Microcurrent device:
Symptomatic relief of chronic intractable pain
Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Neurodyn and Neurodyn Aussie Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the predicate the Vectra Genisys K031077. The Neurodyn Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user protocols. The user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Neurodyn Aussie Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current (MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.
The provided text details a 510(k) summary for the Neurodyn and Neurodyn Aussie Powered Muscle Stimulators, seeking substantial equivalence to the Chattanooga Vectra Genisys K031077. The document outlines essential performance metrics and demonstrates equivalency through non-clinical testing and comparison of device characteristics.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative performance thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Chattanooga Vectra Genisys K031077) by showing that the Neurodyn and Neurodyn Aussie devices share identical or very similar technological characteristics, intended uses, indications for use, safety, and effectiveness.
Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through a detailed comparison, rather than by achieving specific numerical performance targets against a predefined standard.
| Feature | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (Neurodyn / Neurodyn Aussie) | Predicate Device Performance (Vectra Genisys K031077) |
|---|---|---|---|
| Intended Use | Identical to predicate | Identical | |
| Indications for Use | Identical to predicate | Identical | |
| Target Population | Identical to predicate | Identical | |
| Human Factors | Identical to predicate | Identical | |
| Contraindications | Identical to predicate | Identical | |
| Technological Characteristics | Identical (or very similar) to predicate | Identical (e.g., MFAC, materials, software) | Identical |
| Device Material | Similar to predicate | ABS plastic panel, LCD display | ABS plastic panel, LCD display |
| Width (in) | Comparable to predicate | Neurodyn Aussie: 10.6, Neurodyn: 14.6 | 9.75 |
| Height (in) | Comparable to predicate | Neurodyn Aussie: 4.9, Neurodyn: 4.9 | 8.75 |
| Depth (in) | Comparable to predicate | Neurodyn Aussie: 10.4, Neurodyn: 12.4 | 12.75 |
| Weight (lbs) | Comparable to predicate | Neurodyn Aussie: 4.08, Neurodyn: 5.5 | 6 |
| Performance | Identical to predicate | Identical | Identical |
| Biocompatibility | Uses FDA cleared electrodes | FDA cleared electrodes | FDA cleared electrodes |
| Mechanical Safety | Identical to predicate | Identical | Identical |
| Anatomical Sites | Identical to predicate | Identical | Identical |
| Number of Channels | Comparable to predicate | Neurodyn Aussie: 4, Neurodyn: 4 | 2/4 |
| Current Types (Russian, Aussie, Interferential, Microcurrent, TENS, Premodulated) | Similar array of current types to predicate | Varies between Neurodyn and Neurodyn Aussie, but comparable to predicate's offerings. | Vectra Genisys offers all listed. Specific Neurodyn models offer subsets. |
| Voltage Input | Identical to predicate | 100/240V, 50/60Hz Bivolt | 100/240V, 50/60Hz, 1.0A |
| Output | Identical to predicate | +24V 7.3A | +24V 7.3A |
| Electrical Class | Identical to predicate | II | II |
| Electrical Type | Identical to predicate | BF Type | BF Type |
| Method of line current isolation | Comparable to predicate | Double Isolation | Fuse-Two 5.6A Time Lag |
| Patient leakage control (normal condition) | Comparable to predicate (within acceptable limits) | 0.0508mA | 69μA |
| Patient leakage control (single fault condition) | Comparable to predicate (within acceptable limits) | 0.0252mA | 31μA |
| Software Microprocessor | Yes | Yes | Yes |
| Automatic overload trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| Temperature range (transport/storage) | Comparable to predicate | 41°F-122°F | 59°F-104°F |
| Environment operating temperature range | Comparable to predicate | 41°F-113°F | 59°F-104°F |
| Locking feature | Yes | Keyboard lock safety feature | Keyboard lock safety feature |
| Treatment timer with auto shut off | Yes | Yes | Yes |
| Auto test and repeat treatment | Yes | Yes | Yes |
| Safety standards requirements | ISO 13485, IEC 60601-1, IEC 60601-2, IEC 60602-10, CE | Same standards (Vectra Genisys also UL 60602) | ISO 13485, IEC 60601-1, IEC 60601-2, IEC 60602-10, UL 60602 |
| Electromagnetic compatibility | IEC 60601-1-2001/A:2004 | Identical Standard | IEC 60601-1-2001/A:2004 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a non-clinical test design focused on demonstrating substantial equivalence to a predicate device. This typically involves performance verification against a known, cleared device, rather than a test on a patient sample. The data provenance is derived from engineering and design specifications and testing performed by Ibramed, a company based in Brazil (Amparo - Sao Paulo - Brasil). The document does not specify whether this was a retrospective or prospective comparison, but the data itself (device specifications) would inherently be current/prospective for the new devices and historical/retrospective for the predicate device's cleared specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this submission. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Chattanooga Vectra Genisys K031077). The assessment is based on comparison of technical specifications and performance against recognized standards, not on expert consensus regarding patient outcomes or diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert readings or interpretations. The comparison is between documented technical specifications and results of non-clinical engineering tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which is not the nature of a powered muscle stimulator. The submission focuses on demonstrating substantial equivalence of a therapeutic device based on its functional characteristics and safety.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. These are powered muscle stimulator devices, not algorithmic diagnostic tools. Their performance is inherent in their electrical output and physical characteristics, and they are operated by a human user (clinician or patient) as part of a therapeutic regimen.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is the established safety and effectiveness of the legally marketed predicate device (Chattanooga Vectra Genisys K031077) and compliance with relevant international and national electrical safety and medical device standards (e.g., ISO 13485, IEC 60601 series). No clinical outcomes data or pathology samples were used as ground truth for this 510(k) submission.
8. The sample size for the training set
This is not applicable. As a medical device submission based on substantial equivalence to a predicate device and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are likely informed by prior engineering knowledge and regulatory standards, but not a specific "training set" of data for an algorithm.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set mentioned or implied in the context of this 510(k) submission.
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Image /page/0/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of the word "IBRAMED" in a bold, sans-serif font, with a stylized symbol above it. The symbol is composed of horizontal lines and a vertical element that resembles the letter "I" with extensions on either side. The entire logo is in black against a white background.
SECTION 9
510(k) Summary
Neurodyn Powered Muscle Stimulator Neurodyn Aussie Muscle Stimulator
510 (k) Number: K121369
Date of Submission December 13, 2012
Submitter:
IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil
TEL - 5519-3817-9633 FAX - 5519-7816-7980
Official Contact:
Lilian Llull TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
TEL - (305) 206-6777 FAX - (305) 377-0088
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k) premarket notification is in accordance with 21 CFR 807.87.
| Common (Standard) Name: | Powered Muscle Stimulator |
|---|---|
| Trade Name: | Neurodyn Powered Muscle Stimulator |
| Neurodyn Aussie Powered Muscle Stimulator |
Regulation Number & Product Codes:
GZJ - 21 CFR 882.5890-Transcutaneous electrical nerve stimulator for pain relief
IPF - 21 CFR 890.5850-Powered muscle stimulator
LIH - Interferential Current Therapy-Pre-amendment
GZI- 21 CFR 882.5810-External functional neuromuscular stimulator
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Image /page/1/Picture/1 description: The image shows a logo for IBRAMED DEVICE CLASS II. The logo is black and white and features a stylized symbol above the word "IBRAMED". Below the word "IBRAMED" is the text "DEVICE CLASS II". The symbol above the word "IBRAMED" appears to be a stylized letter "I".
Specifications - Both devices were designed according to Existing Technical Standards for the Development of Medical Devices (NBR NBR IEC 60601-1 IEC 60601-1-2 and IEC 60601-2-10 NBR). Predicate Device Identification:
Chattanooga Vectra Genisys K031077
Predicate devices had been submitted and cleared by 510(k) for the same intended uses and indications.
Device Description
Neurodyn and Neurodyn Aussie Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the predicate the Vectra Genisys K031077. The Neurodyn Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user protocols. The user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Neurodyn Aussie Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current (MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz. ·
Indications for Use
As a TENS device:
Symptomatic relief of chronic (long term) intractable pain Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
As an Interferential and Premodulated device:
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
As a Russian device: Temporary relaxation of muscle spasms Prevention or retardation of disuse atrophy in post-injury type conditions Increase local blood circulation
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Image /page/2/Picture/1 description: The image shows the logo for IBRAMED. Below the logo is the text "Muscle re-education" and "Maintaining or increasing range of motion". The logo is black and white and features a stylized "I" shape.
As an Burst modulated alternaing current (Aussie) device: Temporary relaxation of muscle spasms Prevention or retardation of disuse atrophy in post-injury type conditions Increase local blood circulation Muscle re-education Maintaining or increasing range of motion
As a Microcurrent device: Symptomatic relief of chronic intractable pain Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Essential Performance
Neurodyn Muscle Stimulator produces the following currents: Russian / Aussie / Interferential / Tens / Premodulated / Microcurrent
Neurodyn Aussie Muscle Stimulator produces the burst modulated alternating current (Aussie) medium frequency alternate current. The current intensity required for treatment depends on the patient's sensitivity. The treatment should be started with minimum levels of intensity .with gradual increase until the patient achieves the full effect of the treatment.
Electrodes
Electrodes used are Axelgaard K970426. The minimal size of the electrode that can used with the Neurodyn and Neurodyn Aussie is 25cm².
Patient Cables
Utilizes shrouded connectors to meet Lead Wire Connectors Safety Requirements IEC-60601-1 Sub clause 66-3 -c -according to 21 CFR 898. They are designed to be 4.5 feet (1.5 meters) away from the patient. The connector cables are designed to comply with subclause 56.3 ( c ) of the following standard: International Electrotechnical Commission (IEC) 60601-1: Medical Electrical Equipment 60601-1 (1988) Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995)
Declaration of Conformity
This device has been assessed and found compliant. It upholds the highest safety and effectiveness standards.
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Image /page/3/Picture/1 description: The image shows a logo for IBRAMED. The logo is black and white and features the word "IBRAMED" in a bold, sans-serif font. Above the word is a stylized graphic that resembles a capital "I" with horizontal lines extending from the top and bottom. The logo is simple and modern.
Summary of Safety and Effectiveness
-
The Neurodyn and Neurodyn Aussie Muscle Stimulators are substantially equivalent to the Vetra Genisys K031077 manufactured by Chattanooga. All three devices claim similar Indications for Use and Device Characteristics in technological design and materials.
-
The Neurodyn and Neurodyn Aussie Muscle Stimulators do not raise any new issues of Safety and Effectiveness based on their similarities.
-
The devices have continually proven to be safe and effective and demonstrate intended product performance.
Non-Clinical Tests Submitted:
The Ibramed Powered Muscle Stimulators have been tested in accordance with the applicable standards for medical device electrical safety, electromagnetic compatibility and the particular requirements for stimulator nerve and muscle safety.
| EMCl | l est |
|---|---|
| Device Name | Neurodyn Aussie | Neurodyn | Vectra Genisys |
|---|---|---|---|
| K number | 121369 | 121369 | 031077 |
| Manufacturer | Ibramed | Ibramed | Ibramed |
| Intended use | Identical | Identical | Identical |
| Indications for use | Identical | Identical | Identical |
| Target population | Identical | Identical | Identical |
| Human factors | Identical | Identical | Identical |
| Contraindication | Identical | Identical | Identical |
| Device Name | Neurodyn Aussie | Neurodyn | Vectra Genisys |
| K number | --- | --- | K031077 |
| Manufacturer | Ibramed | Ibramed | Chattanooga |
| Technologicalcharacteristics | Identical | Identical | Identical |
| Medium-frequencyalternating current(MFAC) | |||
| Device Material | ABS plastic panelLCD display | ABS plastic panelLCD display | ABS plastic panelLCD display |
| Width (in) | 10.6 | 14.6 | 9.75 |
| Height (in) | 4.9 | 4.9 | 8.75 |
| Depth (in) | 10.4 | 12.4 | 12.75 |
| Weight (lbs) | 4.08 | 5.5 | 6 |
| Performance | Identical | Identical | Identical |
| Biocompatibility | FDA clearedelectrodes | FDA clearedelectrodes | FDA clearedelectrodes |
| Mechanical safety | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Identical |
| Number ofchannels | 4 | 4 | 2/4 |
| Russian | No | Yes | Yes |
| Burst ModulatedAlternatingCurrent (Aussie) | Yes | Yes | Yes |
| Interferential | No | Yes | Yes |
| Microcurrent | No | Yes | Yes |
| TENS | No | Yes | Yes |
| Premodulated | No | Yes | Yes |
| Voltage Input | 100/240V50/60HzBivolt | 100/240V50/60HzBivolt | 100/240V50/60Hz1.0A |
| Output | +24V7.3A+24V7.3A | +24V7.3A+24V7.3A | +24V7.3A+24V7.3A |
| Electrical Class | II | II | II |
| Electrical Type | BF Type | BF Type | BF Type |
| Method of linecurrent isolation | Double Isolation | Double Isolation | Fuse-Two 5.6ATime Lag |
| Patient leakagecontrol-normalcondition | 0.0508mA | 0.0508mA | 69μA |
| Patient leakagecontrol-single faultcondition | 0.0252mA | 0.0252mA | 31μA |
The above comparison chart shows that all four devices are identical in every aspect regarding intended use, indications for use, contraindications, target population and human factors
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|---|---|---|---|---|---|
| -- | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | ---------------------------------- | --- |
| SoftwareMicroprocessor | Yes | Yes | Yes |
|---|---|---|---|
| Automaticoverload trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| Temperaturerange duringtransport andstorage | 41°F-122°F | 41°F-122°F | 59°F-104°F |
| Environmentoperatingtemperaturerange | 41°F-113°F | 41°F-113°F | 59°F-104°F |
| Locking feature | Keyboard locksafety feature | Keyboard locksafety feature | Keyboard locksafety feature |
| Treatment timer | Treatment timerwith auto shut off | Treatment timerwith auto shut off | Treatment timerwith auto shut off |
| Auto test andrepeat | Automatic settingand repeattreatment | Automatic settingand repeattreatment | Automatic settingand repeattreatment |
| Safety standardsrequirements | ISO 13485IEC 60601-1IEC 60601-2IEC 60602-10CE | ISO 13485IEC 60601-1IEC 60601-2IEC 60602-10CE | ISO 13485IEC 60601-1IEC 60601-2IEC 60602-10UL 60602 |
| Electromagneticcompatibility | IEC 60601-1-2001/A:2004 | IEC 60601-1-2001/A:2004 | IEC 60601-1-2001/A:2004 |
The preceding comparison chart shows that all three devices are similar in every aspect. We assessed the indications for use, intended use, technological characteristics, voltages, inputs, outputs, sizes, weight, types of materials, patient cable construction, software construction, user interface, control parameters, level of concern (software), waveforms, treatment times and the results of each treatment.
We have concluded that the Neurodyn and the Neurodyn Aussie are as safe and effective as the Vectra Genisys. The Ibramed devices deliver the same currents for the same intended uses as the Vectra Genisys. Thus, we found them to be substantially equivalent.
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Image /page/6/Picture/0 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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
December 19, 2012
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ibramed Equipamentos Medicos % Ms. Lilian Llull Ibramed U.S. Agent TechLink International 18851 NE 29th Avenue 720 Aventura. FL 33180
K121369 Re:
Trade/Device Name: Neurodyn/Neurodyn Aussie Powered Muscle Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF, LIH, GZI Dated: November 29, 2012 Received: December 5, 2012
Dear Ms. Llull:
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.
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Page 2 - Ms. Lillian Llull
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Neurodyn Series: Neurodyn/ Neurodyn Aussie
510(k) Number: K121369
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain l
- Symptomatic relief of post-traumatic acute pain and post-surgical acute pain -
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post traumatic surqical pain
As a Russian device:
- Temporary relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy in post-injury type conditions -
- Increase local blood circulation -
- Muscle re-education
- Maintaining or increasing range of motion -
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms ー
- Prevention or retardation of disuse atrophy in post-injury type conditions ।
- Increase local blood circulation .
- Muscle re-education l
- Maintaining or increasing range of motion
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain
- Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Prescription Use ____________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation
(ODE) Page 1 of 1
Division of Neurological and I Medicine Devices 510(k) Number
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).