The device NEURODYN II is a four output channel stimulator, operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

The device NEURODYN COMPACT is a two output channel stimulator. operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

AI/ML Overview

The provided submission for the NEURODYN Compact and NEURODYN II devices does not include a detailed study proving the devices meet specific quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed and K021100 300 PV Complete Electrotherapy System by EMPI) based on similar indications for use, operating principles, hardware configuration, and compliance with recognized electrical safety and performance standards.

The acceptance criteria are implicitly defined by compliance with these standards and the established performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	NEURODYN Compact / NEURODYN II Performance
Safety Standards	IEC 60601-1 (General requirements for basic safety and essential performance)
	IEC 60601-1-2 (Electromagnetic compatibility)
	IEC 60601-1-4 (Programmable electrical medical systems)
	IEC 60601-2-10 (Nerve and muscle stimulators)
Material	Biocompatibility (FDA cleared electrodes)
Electrical Output Parameters (Demonstrated to be "similar" or "identical" to predicate devices)	TENS: 0-120mA peak to peak FES: 0-120mA peak to peak Russian: 0-120mA peak to peak
Frequency	0.5-250 Hz
Phase Duration	50-500μs
Current Output (at various loads)	124 mA @ 500Ω, 110mA @ 2KΩ, 39.2mA @ 10KΩ (for Compact/II)
Charge per Phase	58μC
Max. avg. power density	0.038W/cm²
Patient Leakage Control	Normal Condition: 0.0347 mA Single Fault Condition: 0.0162 mA

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not describe a test set involving patient data or clinical trials. The "testing results" mentioned are non-clinical and relate to engineering and electrical safety compliance. Therefore, there is no sample size for a test set or information on data provenance in the context of clinical performance.

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)

Not applicable. The submission focuses on non-clinical engineering and safety standard compliance, not clinical interpretation or ground truth established by medical experts for a diagnostic or treatment outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring expert adjudication.

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

Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm, and its performance inherently involves human-in-the-loop (e.g., a therapist or patient operating the device).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is adherence to recognized international electrical safety and performance standards (IEC 60601 series). These standards define acceptable electrical characteristics, safety mechanisms, and electromagnetic compatibility. The device's performance is measured against the specifications of these standards and comparison to predicate devices, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for IBRAMED. The logo consists of the word "IBRAMED" in bold, sans-serif font, with a stylized symbol above it. The symbol is composed of three horizontal lines on the top and bottom, connected by a vertical line in the center, creating a symmetrical design. The logo is black and white.

510 (k) Number: K131917

Date of Submission: April 29, 2014

Submitter:

IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil

TEL - 5519-3817-9633 FAX - 5519-7816-7980

Official Contact:

Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180

TEL - (305) 377-0077

Common Name:	Powered Muscle Stimulator
Trade Name:	Neurodyn Compact; Neurodyn II
Classification:	Class II
Product Code:	GZJ; GZI; IPF
Classification Panel:	Neurology
Regulation Numbers:	21 CFR 890.5850
Substantial Equivalence:	K121369 Neurodyn/Aussie Powered Muscle
	Stimulator by Ibramed; K021100 300 PV
	Complete Electrotherapy System by EMPI

Indications for Use

Indications for FES waveform:

Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.

Indications for TENS waveform:

Symptomatic relief of chronic (long term) intractable pain
Symptomatic relief of post-traumatic acute pain and post surgical pain

Indications for Russian waveform:

Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions

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Image /page/1/Picture/0 description: The image shows the word "IBRAMED" in bold, black, capital letters. Above the word is a black graphic design that features three horizontal lines on the top and bottom, with a vertical line connecting them in the middle. The design is symmetrical and bold. The overall image has a clean and professional look.

Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion

Device Description

Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)

Characteristics:

TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)

Characteristics:

Device Comparison Table

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Image /page/2/Picture/0 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 symbol that resembles a stylized letter "I" with horizontal lines extending from the top and bottom. There is also the text "BR" and "AMC 31".

510(k) Summary

Device name	NeurodynCompact	Neurodyn II	Neurodyn	300 PV Empi
K Number	Pending	Pending	K121369	K021100
Manufacturer	Ibramed	Ibramed	Ibramed	Empi
Indications for Use	As a FES device:Stimulation of themuscles in theleg andankle of partiallyparalyzedpatients toprovide flexionof the foot andthus improve thepatient's gait.	As a FES device:Stimulation of themuscles in theleg and ankle ofpartiallyparalyzedpatients toprovide flexion ofthe foot and thusimprove thepatient's gait.		As a FES device:Stimulation ofmuscles in the legand ankle ofpartially paralyzedpatients to provideflexion of the footand thus improvethe patient's gait.As a NMES device:Retarding orpreventing disuseatrophyMaintaining orincreasing rangeof motionReeducatingmusclesRelaxation ofmuscle spasmIncreasing localblood circulationPrevention ofvenous thrombosisof the calf musclesimmediately aftersurgery
	As a TENSdevice:Symptomaticrelief of chronic(long term)intractable painSymptomaticrelief of post-traumatic acutepain and postsurgical pain	As a TENSdevice:Symptomaticrelief of chronic(long term)intractable painSymptomaticrelief of post-traumatic acutepain and postsurgical pain	As a TENSdevice:Symptomaticrelief of chronic(long term)intractable painSymptomaticrelief of post-traumatic acutepain and postsurgical pain	As a TENS device:Symptomatic reliefof chronic (longterm) intractablepainSymptomatic reliefof post-traumaticacute pain andpost surgical pain
	As a BurstModulatedAlternating	As a BurstModulatedAlternating	As anInterferential andPremodulateddevice:Symptomaticrelief of chronicpain, acute posttraumatic pain,or acute posttraumaticsurgical painAs a BurstModulatedAlternating	As anInterferential Thisdevice is not beenused as apredicate for theInterferentialwaveform

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Image /page/3/Picture/0 description: The image shows the word "IBRAMED" in bold, black, capital letters. Above the word is a symbol that looks like a stylized "I" or a geometric shape. The symbol is also in black and is composed of horizontal lines and a trapezoidal shape in the middle.

510(k) Summary

			510(k) Summary
	Russian device:	device:	device:
	Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-educationMaintaining orincreasing rangeof motion	Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-educationMaintaining orincreasing rangeof motion	Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-educationMaintaining orincreasing rangeof motionAs a BurstModulatedAlternatingCurrent (Aussie)device:Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-educationAs a Microcurrentdevice:Symptomaticrelief of chronicintractable painSymptomaticrelief of post-traumatic acutepain and postsurgical pain
TechnologicalcharacteristicsMedium-frequency	alternating current(MFAC)	Identical		Identical	Identical
Device Material	ABS plastic panel LCD display	ABS plastic panel LCD display	ABS plastic panel LCD display	ABS plastic panel LCD display
Width (in)	6.89	6.89	14.6	9.75
Height	4.53	4.53	4.9	8.75
Depth	10.83	10.83	12.4	12.75
Number of Channels	2	4	4	4

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Image /page/4/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of the word "IBRAMED" in bold, block letters. Above the word is a stylized graphic that resembles a capital "I" with horizontal lines extending from either side of the top and middle portions of the "I" shape.

Temperature rangeduring transportand storage	59°f-104°f	59°f-104°f	41°f-122°f	-40 to 158°F
Environmentoperatingtemperature range	41°f-113°f	41°f-113°f	41°F-113°F	50 to 104°F
Performance	Identical	Identical	Identical	Identical
Biocompatibility	FDA clearedelectrodes	FDA clearedelectrodes	FDA clearedelectrodes	FDA clearedelectrodes
Mechanical safety	Identical	Identical	Identical	Identical
Anatomical Sites	Identical	Identical	Identical	Identical
Burst ModulatedAlternating Current(Russian)	Yes	Yes	Yes	No
Burst ModulatedAlternating Current(Aussie)	No	No	Yes	No
Interferential	No	No	Yes	Yes
Microcurrent	No	No	Yes	No
TENS	Yes	Yes	Yes	Yes
FES	Yes	Yes	No	Yes
Premodulated	No	No	Yes	Yes
Method of currentisolation	Double Isolation	Double Isolation	Double Isolation	Double Isolation
Patient leakagecontrol-normalcondition	0.0347 mA	0.0347 mA	0.0508mA	0.0502mA
Patient leakagecontrol-single faultcondition	0.0162 mA	0.0162 mA	0.0252mA	0.0248mA
SoftwareMicroprocessor	Yes	Yes	Yes	Yes
Automatic overloadtrip	No	No	No	No
Automatic shut offLocking feature	No	No	No	No
	Keyboard locksafety feature	Keyboard locksafety feature	Keyboard locksafety feature	Keyboard locksafety feature
Treatment timer	Treatment timerwith auto shutoff	Treatment timerwith auto shutoff	Treatment timerwith auto shut off	Treatment timer
Safety standardsrequirementsbiocompatibility	IEC 60601-1IEC 60601-2IEC 60602-10IEC 60101-1-4	IEC 60601-1IEC 60601-2IEC 60602-10IEC 60101-1-4	IEC 60601-1IEC 60601-2IEC 60602-10	IEC 60601-1IEC 60601-2IEC 60602-10
ChemicalComposition	Has no ChemicalComposition	Has no ChemicalComposition	Has no ChemicalComposition	Has no ChemicalComposition
Energy Source	100 to 240 Volts50/60Hz	100 to 240 Volts50/60Hz	100 to 240 Volts50/60Hz	3.0 DC
Electrical OutputParameters	TENS 0 to120mA peak topeakFES 0 to 120mApeak to peakRUSSIA 0 to120mA peak topeak	TENS 0 to120mA peak topeakFES 0 to 120mApeak to peakRUSSIA 0 to120mA peak topeak	FES 0 to 120mApeak to peakRUSSIA 0 to120mA peak topeakInterferential 0 to120mA peak topeakAussie 0 to120mA peak topeakMicro current 0 to990µA peak	NMES 0 to 100mApeak to peakTENS 0 to 50mApeak to peakHV 0 to 300Vpeak
Frequency	0.5-250 Hz	0.5-250 Hz	0.5-250 Hz	0.5-150 Hz
	Phase Duration	Phase Duration	Phase Duration	Phase Duration
Phase Duration	50-500μs	50-500μs	50-500μs	50-400 μs
Current Output	124 mA @500Ω	124 mA @500Ω	125 mA @500Ω	200 mA @ 500Ω
	110mA @2KΩ	110mA @2KΩ	95mA @2KΩ	115 mA @ 2KΩ
	39.2mA @10KΩ	39.2mA @10KΩ	23mA @10KΩ	25 mA @ 10KΩ
Charge per Phase	58μC	58μC	56μC	40@ 500Ω
Max. avg. power density	0.038W/cm2	0.038W/cm2	0.037W/cm²	0.0088W/cm²

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Image /page/5/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of the word "IBRAMED" in large, bold, black letters. Above the word is a symbol that looks like a stylized "I" or a geometric shape. The symbol is also in black and is composed of thick lines and rectangular shapes.

Substantial Equivalence

The subject and the predicate devices have the same intended use, the same operating principle, and are similar in their hardware configuration.

Technology

The Neurodyn II and Neurodyn Compact devices are powered muscle stimulator machines that operate using the TENS, Russian and FES waveforms.

Non-Clinical Testing

This submission includes testing results of the Neurodyn II and Neurodyn Compact.

The devices have been tested according to:

IEC 60601-1 .
IEC 60601-1-2 ●
IEC 60601-1-4 .
. IEC 60601-2-10

IEC 60601-1: The general standard IEC 60601-1 - Medical equipment/medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. It is used as a bench mark for many electrical medical devices. Both the subject and predicate devices comply with this standard.

The standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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Image /page/6/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 three horizontal bars connected by a vertical bar in the center, with angled lines extending from the top bar to the sides.

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. Both the subject and predicate devices comply with this standard.

IEC 60601-2-10: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-2-10:2012 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012.

IEC 60601-1-4: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a quide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

Conclusion

The Neurodyn Compact and Neurodyn II machines are substantially equivalent to the currently legally marketed Neurodyn and 300 PV. The nonclinical testing demonstrates that the subject devices are as safe, as effective and perform as well or better than the legally marketed predicated devices. The IEC testing showed that the subject devices comply with Medical Electrical Device requirements for powered muscle stimulators. The subject devices passed all aspects of the clinical tests. This shows compliance with the standards currently in place for such medical devices. Compliance includes but is not limited to electrical safety (power input, electrical classification, limitation of voltage/energy, etc.).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

April 29, 2014

Ibramed Equipamentos Medicos c/o Ms. Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura. FL 33180

Re: K131917

Trade Name: Neurodyn Compact and Neurodyn II Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ, GZI Dated: April 14, 2014 Received: April 18, 2014

Dear Ms. Conrad:

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 reclassilied 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 (sec above) into cither 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 or any with all the Act s requirements, including, but not limited to: registration and listing (21

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Page 2 of 2 - Ms. Tara Conrad

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131917

Device Name

Neurodyn Compact and Neurodyn II

Indications for Use (Describe)

Indications for FES waveform:

Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the patient's gait.

Indications for TENS waveform:

Symptomatic relief of chronic (long term) intractable pain
Symptomatic relief of post-traumatic acute pain and post surgical pain

Indications for Russian waveform:

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

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

9 -04'00'

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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Regulation Number and Section

§ 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).