Predicate Devices

K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed, K021100 300 PV. Complete Electrotherapy System by EMPI

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on electrical stimulation and safety standards, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is described as operating specific electrical current therapies (TENS and FES) to provide therapeutic benefits such as pain relief and improved gait in partially paralyzed patients, which clearly indicates a therapeutic purpose.

Diagnostic

No

Explanation: The device description and intended use clearly state that this device is a stimulator used for therapeutic purposes (TENS and FES), not for diagnosing medical conditions. It delivers electrical currents to muscles or nerves to alleviate pain or improve muscle function.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a stimulator, power supply, LCD, keyboard, and cabinet, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
Device Function: The described device is a stimulator that applies electrical currents (TENS and FES) to the body for therapeutic purposes (muscle stimulation for gait improvement and pain relief). It does not examine specimens derived from the human body.
Intended Use: The intended uses are directly related to treating conditions within the body, not diagnosing them through the analysis of biological samples.

Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes (comma separated list FDA assigned to the subject device)

GZJ; GZI

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.

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

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.

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

leg and ankle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

licensed health professional.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed; K021100 300 PV. Complete Electrotherapy System by EMPI

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

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.

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

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.

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

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Device name	Neurodyn	Neurodyn	Neurodyn	300 PV Empi
	Portable	Portable TENS
	TENS/FES
K Number	K131923	K131923	K121369	K021100
Manufacturer
Indications for Use	Ibramed
As a 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.	Ibramed	Ibramed	Empi
As a FES device:
Stimulation of
muscles in the leg
and ankle of
partially paralyzed
patients to provide
flexion of the foot
and thus improve
the patient's gait.
As a NMES device:
Retarding or
preventing disuse
atrophy
Maintaining or
increasing range
of motion
Reeducating
muscles
Relaxation of
muscle spasm
Increasing local
blood circulation
Prevention of
venous thrombosis
of the calf muscles
	As a TENS
device:
Symptomatic
relief of chronic
(long term)
intractable pain
Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain	As a TENS
device:
Symptomatic
relief of chronic
(long term)
intractable pain
Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain	As a TENS
device:
Symptomatic
relief of chronic
(long term)
intractable pain
Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain	immediately after
surgery
As a TENS device:
Symptomatic relief
of chronic (long
term) intractable
pain
Symptomatic relief
of post-traumatic
acute pain and
post surgical pain
			AS an
Interferential and
Premodulated
device:
Symptomatic
relief of chronic
pain, acute post
traumatic pain,
or acute post
traumatic
surgical pain	As an
Interferential This
device is not been
used as a
predicate for the
Interferential
waveform

			As a Burst
Modulated
Alternating
Current -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

Prevention or
retardation of
disuse atrophy in
post-injury type
conditions

Increase local
blood circulation

Muscle re-
education | |
| | | | As a Microcurrent
device:
Symptomatic
relief of chronic
intractable pain

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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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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

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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 peak
TENS	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

7

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

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