K Number

Validate with FDA (Live)

Device Name

NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS

Manufacturer

TECHLINK INTERNATIONAL

Date Cleared

2014-07-03

(372 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Indications for FES device:

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 device:

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

Device Description

The device NEURODYN PORTABLE TENS/FES is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC converter, with independent controls, Liquid Crystal Display. with 4 ½ digits, mechanical contact keyboard and ABS cabinet.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation)
The equipment must be used only under the prescription and supervision of a licensed health professional.

The device NEURODYN PORTABLE TENS is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC, with independent controls, Liquid Crystal Display with 4 ½ digits, mechanical contact keyboard and ABS cabinet.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation)
The equipment must be used only under the prescription and supervision of a licensed health professional.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Neurodyn Portable TENS/FES and Neurodyn Portable TENS devices. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving independent effectiveness through a de novo study with specific performance acceptance criteria.

Therefore, the document does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically seen for novel devices. Instead, it relies on demonstrating that the new devices are as safe and effective as existing legally marketed devices.

However, based on the information provided, we can infer the "acceptance criteria" were related to achieving substantial equivalence to the predicate devices and complying with relevant safety standards. The "study" proving this was a non-clinical assessment and IEC testing.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the new devices perform as safely and effectively as the predicate devices, and comply with relevant safety standards. The "reported device performance" section illustrates this equivalence.

Acceptance Criteria (Implied for Substantial Equivalence and Safety)	Reported Device Performance (Neurodyn Portable TENS/FES & Neurodyn Portable TENS - Subject Devices referenced by K131923)	Reference to Predicate Device (e.g., K121369 Neurodyn/Aussie Powered Muscle Stimulator, K021100 300 PV Complete Electrotherapy System)
Intended Use Equivalence	Identical indications for use as TENS and FES devices.	Predicate devices have matching indications for TENS and FES capabilities (where applicable).
Operating Principle Equivalence	Operates using TENS and/or FES waveforms.	Predicate devices operate on the same fundamental principles of electrical stimulation.
Hardware Configuration Similarity	Similar device description (two output channels, LCD, mechanical keyboard, ABS cabinet).	Similar physical and functional characteristics to predicate devices.
Technological Characteristics Equivalence (Medium-frequency alternating current - MFAC)	Identical MFAC characteristics.	Identical to predicate devices.
Device Material Equivalence	ABS plastic panel, LCD display.	Identical to predicate devices.
Output Electrical Parameters Equivalence	TENS 0 to 100mA peak to peak; FES 0 to 100mA peak to peak (for TENS/FES model).	Comparable to predicate devices (e.g., K121369 FES 0 to 120mA, K021100 TENS 0 to 50mA, NMES 0 to 100mA, but overall within-range for the therapy type).
Modes of Stimulation Equivalence	TENS, FES (for TENS/FES model).	Comparable to relevant modes of stimulation in predicate devices.
Frequency Range Equivalence	0.5 to 250 Hz.	Comparable to predicate devices (0.5 to 250 Hz for K121369, 0.5 to 150 Hz for K021100).
Phase Duration Equivalence	50 to 500 us.	Comparable to predicate devices (50 to 500 us for K121369, 50 to 400 us for K021100).
Current Output Equivalence	104 mA.	Comparable to predicate devices (125 mA for K121369, 200 mA for K021100).
Total Charge per Pulse Equivalence	52.	Comparable to predicate devices (57 for K121369, 40 for K021100).
Maximum Average Power Density Equivalence	0.024 W/cm^2 (TENS only: 0.027 W/cm^2).	Comparable to predicate devices (0.040 W/cm^2 for K121369, 0.0088 W/cm^2 for K021100).
Electrical Safety Compliance	Complied with IEC 60601-1, IEC 60601-2, IEC 60602-10 (*Note: IEC 60602-10 is likely a typo/misread. It should be IEC 60601-2-10 or
IEC 60601-1-10 or IEC 62304 related to software/programming if "biocompatibility" is mentioned in relation to it).*	Predicate devices are also subject to these standards. Non-clinical testing demonstrated compliance.
Patient Leakage Control	Normal condition: 0.0497 mA; Single fault condition: 0.0245 mA.	Comparable to predicate devices (K121369: 0.0508mA normal, 0.0252mA single fault; K021100: 0.0502mA normal, 0.0248mA single fault).
Safety Features	Software, microprocessor, keyboard lock safety feature, treatment timer with auto shut off.	Present and comparable to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) submission based on non-clinical testing and comparison to predicate devices, not a clinical trial with a "test set" of patients in the typical sense.

Sample Size for Test Set: Not applicable in the context of a clinical test set. The validation was based on comprehensive engineering and safety testing.
Data Provenance: The data provenance for the non-clinical testing would be from the manufacturer's (Ibramed, Brazil) own testing facilities or accredited third-party laboratories. The document indicates the submission country as Brazil. The data is based on the technical specifications and test results of the manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" here is compliance with established electrical safety standards (IEC 60601 series) and demonstrating that the device's technical specifications and intended use are substantially equivalent to legally marketed predicate devices. This typically involves engineers and regulatory specialists evaluating test reports and device specifications against standards and predicate device information, not clinical experts establishing a ground truth for a diagnostic or therapeutic outcome.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication by multiple readers or experts in a clinical sense. The evaluation was a technical and regulatory review overseen by the FDA.

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 is a medical device for electrical stimulation (TENS/FES), not an AI-powered diagnostic or assistive tool for human readers/clinicians, and no MRMC study was conducted or mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. These are physical hardware devices that apply electrical stimulation directly. There is no "algorithm" in the sense of AI or image processing being evaluated for standalone performance. The device itself operates in a standalone manner as a medical device, but this question typically refers to computational algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily:

Compliance with IEC 60601 series standards: Demonstrated through engineering test reports for electrical safety, electromagnetic compatibility, and basic performance.
Technical Specifications: Verification that the device's electrical output parameters (current, frequency, phase duration), physical dimensions, and safety features align with the stated design and are within acceptable ranges for the intended use and comparable to predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for these types of electrical stimulation devices in a 510(k) submission unless it was an adaptive algorithm, which is not the case here.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set established.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in bold, sans-serif font. The symbol is composed of thick, horizontal lines connected by vertical elements, creating a geometric design. The overall impression is modern and corporate.

JUL 0 3 2014

510(k) Summary

510 (k) Number: K131923 Date of Submission: July 1, 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 PO Box 694125 Miami, FL 33269

TEL - (305) 377-0077

Common Name: Trade Name:

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Classification: Product Code: Classification Panel: Regulation Numbers: Substantial Equivalence: External Functional Neuromusclar Stimulator Neurodyn Portable TENS; Neurodyn Portable TENS/FES

Class II GZJ; GZI Neurology 21 CFR 882.5890 and 21 CFR 882.5810 K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed; K021100 300 PV. Complete Electrotherapy System by EMPI

Indications for Use

Indications for FES device:

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 device:

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

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Image /page/1/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized "I" shape above the word "IBRAMED" in a bold, sans-serif font. Below the word "IBRAMED" is the phrase "Device Description" in a smaller, sans-serif font. The logo is black and white.

Neurodyn Poratble TENS/FES

Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation)

The equipment must be used only under the prescription and supervision of a licensed health professional.

Neurodyn Portable Tens/Fes

Characteristics:

TENS: two 100mA peak to peak channels FES: two 100mA peak to peak channels Input Power: 15VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F Electrical Class: Class II Electrical Protection: Type BF

Neurodyn Portable TENS

Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation)

The equipment must be used only under the prescription and supervision of a licensed health professional.

Neurodyn Portable Tens

Characteristics:

TENS: two 100mA peak to peak channels

Input Power: 15VA

Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F Electrical Class: Class II

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Image /page/2/Picture/0 description: The image shows the logo for IBRAMED, which is a black, stylized "I" with three horizontal lines above the word "IBRAMED". Below the logo, the text "Electrical Protection: Type BF" is written in a smaller font. The logo and text are all in black and are set against a white background.

Device Comparison Table

Device name	Neurodyn	Neurodyn	Neurodyn	300 PV Empi
	Portable	Portable TENS
	TENS/FES
K Number	K131923	K131923	K121369	K021100
ManufacturerIndications for Use	IbramedAs a FES device:Stimulation of themuscles in the legand ankle ofpartiallyparalyzedpatients toprovide flexion ofthe foot and thusimprove thepatient's gait.	Ibramed	Ibramed	EmpiAs 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 muscles
	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	immediately aftersurgeryAs a TENS device:Symptomatic reliefof chronic (longterm) intractablepainSymptomatic reliefof post-traumaticacute pain andpost surgical pain
			AS anInterferential andPremodulateddevice:Symptomaticrelief of chronicpain, acute posttraumatic pain,or acute posttraumaticsurgical pain	As anInterferential Thisdevice is not beenused as apredicate for theInterferentialwaveform

			As a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-educationMaintaining orincreasing rangeof motion
			As a BurstModulatedAlternatingCurrent (Aussie)device:Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-education
			As a Microcurrentdevice:Symptomaticrelief of chronicintractable painSymptomaticrelief of post-traumatic acutepain and postsurgical pain
TechnologicalcharacteristicsMedium-frequencyalternating current(MFAC)	Identical	Identical	Identical	Identical
Device Material	ABS plastic panelLCD display	ABS plastic panelLCD display	ABS plastic panelLCD display	ABS plastic panelLCD display
Width (in)	3.07	3.07	6.8	9.75
Height	1.97	1.97	4.9	8.75

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Image /page/3/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized letter "I" above the word "IBRAMED" in bold, uppercase letters. The "I" is composed of three horizontal bars connected by two vertical bars, creating a geometric design.

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. .

・

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Image /page/4/Picture/0 description: The image shows a logo for IBRAMED. The logo is black and white and features a stylized "I" shape above the word "IBRAMED" in bold, capital letters. Below the word "IBRAMED" is a horizontal line, and below that is the number 5.83.

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ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

・

Depth	5.83	5.83	12.4	12.75
Number of	2	2	4	র্ব
Channels
Temperature	-58°f-122°f	-58°f-122°f	45°f-110°f	-40 to 158°F
range during
transport and
storage
Environment	23°F-113°F	23°F-113°F	45°F-110°F	50 to 104°F
operating
temperature range
Method of current	Double Isolation	Double Isolation	Double Isolation	Double Isolation
isolation
Patient leakage	0.0497 mA	0.0497 mA	0.0508mA	0.0502mA
control-normal
condition
Patient leakage	0.0245 mA	0.0245 mA	0.0252mA	0.0248mA
control-single fault
condition
Software	Yes	Yes	Yes	Yes
Microprocessor
Automatic	No	No	No	No
overload trip
Automatic shut off	No	No	No	No
Locking feature	Keyboard lock	Keyboard lock	Keyboard lock	Keyboard lock
	safety feature	safety feature	safety feature	safety feature
Treatment timer	Treatment timer	Treatment timer	Treatment timer	Treatment timer
	with auto shut off	with auto shut off	with auto shut off
Safety standards	IEC 60601-1	IEC 60601-1	IEC 60601-1	IEC 60601-1
requirements	IEC 60601-2	IEC 60601-2	IEC 60601-2	IEC 60601-2
biocompatibility	IEC 60602-10	IEC 60602-10	IEC 60602-10	IEC 60602-10
Chemical	Has no Chemical	Has no Chemical	Has no Chemical	Has no Chemical
Composition	Composition	Composition	Composition	Composition
Energy Source	AC/9.0 DC	AC/9.0 DC	a.0 DC	3.0 DC
Electrical Output	TENS 0 to 100mA	TENS 0 to 100mA	FES 0 to 120mA	NMES 0 to 100mA
Parameters	peak to peak	peak to peak	peak to peak	peak to peak
	FES 0 to 100mA		RUSSIA 0 to	TENS 0 to 50mA
	peak to peak		120mA peak to	peak to peak
		t	peak	HV 0 to 300V peak
			Interferential 0 to
			120mA peak to
			peak
			Aussie 0 to
			120mA peak to
			peak
			Micro current 0 to
Modes of	TENS	TENS	990pA peakTENS	TENS
stimulation	FES		FES	NMES
			INTERFERENTIAL	INTERFERENTIAL
			RUSSA	HV
			AUSSIE
			DIRECT CURRENT
			MICRO CURRENT
Frequency Hz	0.5 to 250	0.5 to 250	0.5 to 250	0.5 to 150
Phase Duration us	50 to 500	50 to 500	50 to 500	50 to 400
Current Output	104	104	125	200
mA
Total Charge per	52	52	57	40
pulse (two
phases).				/
Maximum Average	0.024	0.027	0.040	0.0088
Power Density

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Image /page/5/Picture/0 description: The image shows a logo for IBRAMED. The logo is black and white and features a stylized letter "I" above the word "IBRAMED". Below the word "IBRAMED" is the text "W/cm^2".

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 Portable devices are External Functional Neuromusclar Stimulator machines that operate using the tens and/or fes waveforms.

Conclusion

The Neurodyn Portable TENS and Neurodyn Portable TENS/FES machines are substantially equivalent to the currently legally marketed Neurodyn and 300 PV. The non-clinical 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 external functional neuromusclar stimulator. 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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Public Health Service

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

July 3, 2014

Ibramed Equipamentos Medicos C/O TechLink International Consulting Attn: Tara Conrad 18851 NE 29th Avenue Suite 720 Aventura, FL 33180

Re: K131923

Trade Name: Neurodyn Portable TENS/FES and Neurodyn Portable TENS Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI, GZJ Dated: June 23, 2014 Received: June 25, 2014

Dear Ms. Conrad:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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

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Page 2 of 2 - Ms. Tara Conrad

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 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/Resources/or 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/ReportalProblem/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 hup://www.fdagov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely vours.

Felipe Aquel -S

for

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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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Neurodyn Portable TENS and Neurodyn Portable TENS/FES Device Name:_

Indications For Use:

Indications for FES device:

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 device:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Felipe Aguel Date: 2014.07.03 17:01:44 -04'00' -2

Page 1 of __

Page 16 of 16 K131923 RTA

Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).