Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard electrical stimulation therapies (TENS, FES, Russian) and the physical characteristics of the device, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is used to stimulate muscles, relieve pain, and improve patient gait, which are all therapeutic purposes.

Diagnostic

No

The device description and indications for use clearly show that NEURODYN II and NEURODYN COMPACT are therapeutic electrical stimulators used for muscle stimulation, pain relief, and muscle re-education. They do not perform any diagnostic functions like detecting, identifying, or monitoring medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical hardware components such as a stimulator with output channels, power supply, graphic display, mechanical keyboard, and ABS cabinet. It also mentions electrical current therapies and electrical feed characteristics, indicating it is a physical 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 used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is a stimulator used for electrical current therapies (TENS, FES, Russian). It applies electrical stimulation to muscles and nerves externally.
Intended Use: The intended uses described (muscle stimulation for gait improvement, pain relief, muscle spasm relaxation, etc.) are all related to applying electrical current to the body for therapeutic purposes.
Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.

Therefore, the device described is a therapeutic electrical stimulator, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes

GZJ, GZI, IPF

Device Description

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

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

Not Found

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

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.).

Key Metrics

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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

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

Device Comparison Table

2

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

י

"

:

| Device name | Neurodyn
Compact | 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 the
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 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. | | 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
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 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 |
| | As a Burst
Modulated
Alternating | As a Burst
Modulated
Alternating | As an
Interferential and
Premodulated
device:
Symptomatic
relief of chronic
pain, acute post
traumatic pain,
or acute post
traumatic
surgical pain
As a Burst
Modulated
Alternating | As an
Interferential This
device is not been
used as a
predicate for the
Interferential
waveform |

3

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:
	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	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	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

Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain | | | | |
| Technological
characteristics
Medium-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 | | | |

:

4

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 range
during transport

and storage	59°f-104°f	59°f-104°f	41°f-122°f	-40 to 158°F
Environment
operating
temperature range	41°f-113°f	41°f-113°f	41°F-113°F	50 to 104°F
Performance	Identical	Identical	Identical	Identical
Biocompatibility	FDA cleared
electrodes	FDA cleared
electrodes	FDA cleared
electrodes	FDA cleared
electrodes
Mechanical safety	Identical	Identical	Identical	Identical
Anatomical Sites	Identical	Identical	Identical	Identical
Burst Modulated
Alternating Current
(Russian)	Yes	Yes	Yes	No
Burst Modulated
Alternating 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 current
isolation	Double Isolation	Double Isolation	Double Isolation	Double Isolation
Patient leakage
control-normal
condition	0.0347 mA	0.0347 mA	0.0508mA	0.0502mA
Patient leakage
control-single fault
condition	0.0162 mA	0.0162 mA	0.0252mA	0.0248mA
Software
Microprocessor	Yes	Yes	Yes	Yes
Automatic overload
trip	No	No	No	No
Automatic shut off
Locking feature	No	No	No	No
	Keyboard lock
safety feature	Keyboard lock
safety feature	Keyboard lock
safety feature	Keyboard lock
safety feature
Treatment timer	Treatment timer
with auto shut
off	Treatment timer
with auto shut
off	Treatment timer
with auto shut off	Treatment timer
Safety standards
requirements
biocompatibility	IEC 60601-1
IEC 60601-2
IEC 60602-10
IEC 60101-1-4	IEC 60601-1
IEC 60601-2
IEC 60602-10
IEC 60101-1-4	IEC 60601-1
IEC 60601-2
IEC 60602-10	IEC 60601-1
IEC 60601-2
IEC 60602-10
Chemical
Composition	Has no Chemical
Composition	Has no Chemical
Composition	Has no Chemical
Composition	Has no Chemical
Composition
Energy Source	100 to 240 Volts
50/60Hz	100 to 240 Volts
50/60Hz	100 to 240 Volts
50/60Hz	3.0 DC
Electrical Output
Parameters	TENS 0 to
120mA peak to
peak
FES 0 to 120mA
peak to peak
RUSSIA 0 to
120mA peak to
peak	TENS 0 to
120mA peak to
peak
FES 0 to 120mA
peak to peak
RUSSIA 0 to
120mA peak to
peak	FES 0 to 120mA
peak to peak
RUSSIA 0 to
120mA peak to
peak
Interferential 0 to
120mA peak to
peak
Aussie 0 to
120mA peak to
peak
Micro current 0 to
990µA peak	NMES 0 to 100mA
peak to peak
TENS 0 to 50mA
peak to peak
HV 0 to 300V
peak
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

:

.

5

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

6

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.).

7

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

8

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

9

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.

10

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