. Relaxation of muscle spasms
Prevention or retardation of disuse atrophy .
. Increase local blood circulation
Muscle re-education .
. Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
TENS for:
ロ
Symptomatic relief of chronic, intractable pain.
· Management of pain associated with post-traumatic or post-operative conditions.

Device Description

The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.
The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.
It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.

AI/ML Overview

This descriptive study compares the Tone-A-Matic device to a predicate device, Winstim (K102190). It does not present a standalone clinical study with an acceptance criterion and reported device performance in the traditional sense of a diagnostic or therapeutic efficacy trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed device through non-clinical testing and comparison of technical specifications and intended uses.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence rather than a clinical performance study with predefined acceptance criteria for a specific outcome, a direct "acceptance criteria" table for device performance (e.g., sensitivity, specificity, accuracy) is not applicable or provided. Instead, the acceptance criteria for a 510(k) are typically met by demonstrating that the new device has "the same intended use" and "similar technological characteristics" as a predicate device and raises "no new questions of safety or effectiveness."

The "reported device performance" in this context is the technical specifications and safety/EMC compliance, which are compared to the predicate device to justify substantial equivalence.

Feature	PREDICATE DEVICE (Winstim) Performance	NEW DEVICE (Tone-A-Matic) Performance	Acceptance Criteria (Implied by Substantial Equivalence)
Intended Use	Relax muscle spasms, prevent disuse atrophy, increase local blood circulation, muscle re-education, increase range of motion, prevent venous thrombosis (Russian & EMS); Symptomatic relief of chronic/intractable pain, manage post-traumatic/post-operative pain (TENS); Therapeutic deep heat (Ultrasound).	Relax muscle spasms, prevent disuse atrophy, increase local blood circulation, muscle re-education, increase range of motion, prevent venous thrombosis (Russian & EMS); Symptomatic relief of chronic/intractable pain, manage post-traumatic/post-operative pain (TENS).	Identical or highly similar intended uses. (Met, excluding Ultrasound function).
Power Source	24 VDC Adaptor and rechargeable battery	24 VDC Adaptor and rechargeable battery operated	Equivalent power source. (Met)
Waveform	Russian: Sinusoidal; TENS: Square Wave; EMS: Square Wave	Russian: Square Wave; TENS: Square Wave; EMS: Square Wave	Similar waveforms or justification for differences not impacting safety/effectiveness. (Difference noted for Russian, but considered insignificant for overall equivalence).
Max Output Voltage	Russian: 50 Vpp @ 500Ω; TENS: 57 Vpp @ 500Ω, 225 Vpp @ 2KΩ; EMS: 57 Vpp @ 500Ω, 225 Vpp @ 2KΩ	Russian: 50 Vpp @ 500Ω, 60Vpp @2KΩ; TENS: 57 Vpp @ 500Ω, 90Vpp @2KΩ; EMS: 57 Vpp @ 500Ω, 90Vpp @2KΩ	Output voltage within comparable and safe ranges. (Comparability assessed).
Max Output Current	Russian: 100 mA @ 500Ω; TENS: 114 mA @ 500Ω, 112.5 mA @ 2KΩ; EMS: 114 mA pp @ 500Ω, 112.5 mA @ 2KΩ	Russian: 100 mA pp @ 500Ω, 30mA pp @ 2KΩ; TENS: 114 mA @ 500Ω, 45mA pp @ 2KΩ; EMS: 114 mA pp @ 500Ω, 45mA pp @ 2KΩ	Output current within comparable and safe ranges. (Comparability assessed).
Number of Outputs	7 modes (for Winstim, unclear if this means outputs)	8 outputs	Number of outputs/channels comparable or justified difference. (Difference, but likely not impact to safety/effectiveness).
Channels	Synchronous; Ch 1&2 isolated; Electrotherapy & Ultrasound isolated	Synchronous; Ch 1&2 isolated	Isolation features for safety. (Met, except for Ultrasound specific isolation which new device lacks).
Net Charge	All modes: 0 μC	All modes: 0 μC	No net charge for safety. (Met)
Max Phase Charge	Russian: 20.00 μC; TENS: 22.5 μC; EMS: 22.5 μC	Russian: 20.00 μC; TENS: 22.5 μC; EMS: 22.5 μC	Max phase charge within safe limits. (Met)
Max Current Density	Russian: 3.87 mA/cm2; TENS: 4.41 mA/cm2; EMS: 4.41 mA/cm2	Russian: 3.87 mA/cm2; TENS: 4.41 mA / cm2; EMS: 4.41 mA / cm2	Current density within safe limits. (Met)
Max Power Density	Russian: 0.246 Watt/cm²; TENS: 0.064 Watt/cm²; EMS: 0.064 Watt/cm²	Russian: 0.193 Watt/cm2; TENS: 0.251 Watt / cm2; EMS: 0.251 Watt / cm2	Power density within safe limits. (Comparability assessed).
Treatment Time	1 - 100 MINUTES	1 - 60 MINUTES	Treatment time range acceptable. (Difference, but within typical usage and safe limits).
Safety Standards	Not explicitly listed, but implied by 510(k) clearance	IEC 60601-1. Ed3.0, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, ISO 14971: 2007	Compliance with relevant international safety and EMC standards. (Met)
Software Guidance	Not explicitly listed, but implied by 510(k) clearance	FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices	Compliance with relevant software guidance. (Met)

The study (the 510(k) submission) "proves" the device meets acceptance criteria by presenting a detailed comparison of its technical specifications and intended use against a legally marketed predicate device (Winstim, K102190). The conclusion states: "The electrical stimulation provided by the Tone-A-Matic device is similar to that of Predicate Device Winstim... Tone-A-Matic has same intended use and similar technological characteristics... and the verification and validation tests contained in this submission demonstrate that the differences... still maintain the same safety and effectiveness as that of the cleared predicate."

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

This is not a clinical study involving human or animal subjects for performance testing in the sense of a "test set." The "test set" here refers to the data generated from non-clinical bench testing of the device's electrical characteristics and compliance with standards. Therefore:

Sample size: Not applicable in the context of a clinical test set. The submission refers to non-clinical tests performed on the Tone-A-Matic device itself to verify its specifications and compliance with standards. The number of individual devices tested or the extent of that testing is not specified, but it would typically involve one or more production units subjected to comprehensive engineering tests.
Data provenance: The data would be generated in a laboratory setting by the manufacturer, Tone-A-Matic International Inc., during the design, development, and verification stages of the device. It is retrospective in the sense that these tests were performed to support the premarket submission. The country of origin for the data generation would be where the manufacturer conducted these tests (likely Canada or the manufacturing location, if different).

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

Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For this type of submission, "ground truth" for the device's performance is established by engineering measurements and compliance with established international standards (e.g., IEC 60601 series). The "experts" involved would be the engineers and quality assurance professionals performing and reviewing these tests, ensuring they align with the device's design specifications and regulatory requirements. Their qualifications would be in electrical engineering, biomedical engineering, and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. As no human readers or clinical interpretations are involved in establishing performance or ground truth for this non-clinical submission, there is no adjudication method. The outcome is determined by direct measurement and comparison to predefined technical standards.

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/TENS unit, not an AI-assisted diagnostic or therapeutic technology that would typically be evaluated with MRMC studies comparing human reader performance.

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

Not applicable in the typical sense of AI algorithm performance. This device is an electrotherapy device. Its "performance" is its ability to generate specific electrical waveforms and outputs as designed and comply with safety standards. The non-clinical tests performed (electrical safety, EMC, software verification) represent the standalone assessment of the device against its specifications and applicable standards.

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

The "ground truth" used for this submission is based on:

Engineering specifications and measurements: The device is designed to produce specific electrical parameters (voltage, current, waveforms, phase charge, etc.). The non-clinical tests verify that the device's actual output matches these design specifications within acceptable tolerances.
International safety and performance standards: Compliance with standards like IEC 60601 series, ISO 14971, and FDA software guidance serves as a "ground truth" for safe and effective design and manufacturing.
Predicate device characteristics: The ground truth for demonstrating substantial equivalence is the established safety and effectiveness of the legally marketed predicate device (Winstim, K102190). The new device is compared directly to these known characteristics.

8. The Sample Size for the Training Set

Not applicable. As this device does not involve machine learning or AI algorithms, there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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the state the states

Image /page/0/Picture/2 description: The image shows the logo for Tone-A-Matic. The logo is in black and white and features a stylized "T" with a microphone incorporated into the design. Below the main logo, there is smaller text that reads "International Incorporated."

510(k) Summary

Submitter's Name	: TONE-A-MATIC INTERNATIONAL INC.
Contact person	: Ms. ANNIE KORDIUK
E-mail	: toneamaticint@gmail.com
Phone	: +1-905-501-0457
Fax	: +1-905-501-9290
Date of Summary Submission	: April 28, 2014
Resubmitting on.	: N.A.

Anna Herkules

Name of Person and Signature (Ms. ANNIA KORDIUK-Operations Manager)

145 TRANSFARING E CHIT 19 GMT 19 JANSHISSAURA, CHILAZ 3L3
14 SECT 1940 491 414 GMT 105 SU1 9290

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NEW DEVICE FOR WHICH SUBMITTING

Common or Usual Name	:POWERED MUSCLE STIMULATOR.MUSCLE STIMULATORTRANSCUTANEOUS ELECTRICAL NERVESTIMULATION FOR PAIN RELIEF
Classification name	: Powered muscle stimulator(21 CFR 890.5850, Product Code IPF)AndTranscutaneous electrical nerve stimulator for pain(21 CFR 882.5890, Product Code GZJ)
Trade Name	:Tone-A-Matic
Model Name of Device	:TDB 68

LEGALLY MARKETED DEVICEWinstim	: Ultrasound and Powered Muscle Stimulator
Classification Name	: Ultrasound and Muscle stimulator
510(k) Number :	: K102190
ManufacturerAddress	:Johari Digital Healthcare Ltd.:Electronic Hardware Technology ParkG-582, 583,E.P.I.P., BoranadaJodhpur (Rajasthan)-342008INDIA

DESCRIPTION OF NEW DEVICE Tone-A-Matic

The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.

It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.

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Tone-A-Matic comes complete with all the necessary components of same quality and standards as being provided with predicate device Winstim. Below is a list of items that are included:

S No.	Particulars	Quantity
1.	Electrode Cable (2Pin)	08 nos.
2.	Self Adhesive Electrodes	16 nos.
3.	Adaptor with AC Cord	01 no.
4.	Instruction Manual	01 no.

ACCESSORIES LIST

INTENDED USE OF NEW DEVICE Tone-A-Matic

Tone-A-Maticis indicated to be used for

L Russian and EMS for:

. Relaxation of muscle spasms
Prevention or retardation of disuse atrophy .
. Increase local blood circulation
Muscle re-education .
. Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

TENS for:

ロ

Symptomatic relief of chronic, intractable pain.
· Management of pain associated with post-traumatic or post-operative conditions.

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DESCRIPTION OF PREDICATE DEVICE Winstim

The product, is standalone, portable electric and ultrasound stimulator, used in physiotherapy for rehabilitation and pain relieving purposes. The physiotherapist will be able to program the unit and initiate stimulation application through touch-screen panel interface. The configured stimulation then can be applied through in-built electro stimulator module or peripheral ultrasound head. The unit can be powered up through external AC adapter, in addition to portable (re-chargeable) battery-driven operation. Units are supplied with electrodes listed in 510(k) K050469, typically 2X2 inch.

INTENDED USE OF PREDICATE DEVICE Winstim

□ Russian and EMS for:

Relaxation of muscle spasms ●
Prevention or retardation of disuse atrophy .
. Increase local blood circulation
Muscle re-education ●
Maintaining or increasing range of motion ●
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

0 TENS for:

· Symptomatic relief of chronic, intractable pain.
· Management of pain associated with post-traumatic or post-operative conditions.

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TECHNICAL SPECIFICATION OF NEWD DEVICE Tone-A-Matic

S.No.	Description	New Device
		Tone-A-Matic
1.	Power Source	24 VDC Adaptor and rechargeable battery operated
2.	Waveform	1. RUSSIAN - Square Wave2. TENS - Square Wave3. EMS - Square Wave
3.	Maximum OutputVoltage	1. RUSSIAN -50 Vpp @ 500Ω60Vpp @2KΩ2. TENS -57 Vpp @ 500Ω90Vpp @2KΩ3. EMS -57 Vpp @ 500Ω90Vpp @2KΩ
4.	Maximum OutputCurrent	1. RUSSIAN -100 mA pp @ 500Ω30mA pp @ 2KΩ2. TENS -114 mA @ 500Ω45mA pp @ 2KΩ3. EMS -114 mA pp @ 500Ω45mA pp @ 2KΩ
5.	Number Of Output	8
6.	Number of OutputChannels Synchronousor Alternating?	Synchronous(a) Channel 1 and 2 are completely isolated. Onlypower supply and ground are commonConfirms to ANSI 3.2.3.2
7.	Net Charge	1. RUSSIAN - 0 μC2. TENS - 0 μC3. EMS - 0 μC
8.	Maximum Phase Charge	1. RUSSIAN - 20.00 μC2. TENS - 22.5 μC3. EMS - 22.5 μC
9.	Maximum Currentdensity	1. RUSSIAN - 3.87 mA/cm2 @ Load of 500 Ohm2. TENS - 4.41 mA / cm2 @ Load of 500 Ohm3. EMS - 4.41 mA / cm2 @ Load of 500 Ohm
10.	Maximum Power Density	1. RUSSIAN - 0.193 Watt/cm2 @ Load of 500 ohm2. TENS - 0.251 Watt / cm2 @ Load of 500 Ω3. EMS - 0.251 Watt / cm2 @ Load of 500 Ω
11.	Treatment Time	1 - 60 MINUTES

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TECHNICAL SPECIFICATION OF THE PREDICATE DEVICE Winstim

S.No.	Description	PREDICATE DEVICE
		Winstim ( K102190)
1.	Power Source	24 VDC Adaptor and rechargeable battery operated
2.	Waveform	1. RUSSIAN - Sinusoidal2. TENS - Square Wave3. EMS - Square Wave
3.	Maximum OutputVoltage	1. RUSSIAN -50 Vpp @ 500Ω2. TENS -57 Vpp @ 500Ω225 Vpp @ 2KΩ3. EMS -57 Vpp @ 500Ω225 Vpp @ 2KΩ
4.	Maximum OutputCurrent	1. RUSSIAN -100 mA @ 500Ω2. TENS -114 mA @ 500Ω112.5 mA @ 2KΩ3. EMS -114 mA pp @ 500Ω112.5 mA @ 2KΩ
5.	Number Of OutputModes	7
6.	Number of OutputChannels Synchronousor Alternating?	Synchronous(a) Channel 1 and 2 are completely isolated. Onlypower supply and ground are common(b) Electrotherapy and Ultrasound are also isolated.They have their own Hardware, which arecompletely isolated. Confirms to ANSI 3.2.3.2
7.	Net Charge	1. RUSSIAN - 0 µC2. TENS - 0 µC3. EMS – 0 µC
8.	Maximum Phase Charge	1. RUSSIAN - 20.00 µC

		2. TENS - 22.5 $\mu$ C
		3. EMS - 22.5 $\mu$ C
9.	Maximum Currentdensity	1. RUSSIAN - 3.87 mA/cm2 @ Load of 500 Ohm
		2. TENS - 4.41 mA / cm2 @ Load of 500 Ohm
		3. EMS - 4.41 mA / cm2 @ Load of 500 Ohm .
10.	Maximum Power Density	1. RUSSIAN - 0.246 Watt/cm² @ Load of 500 Ohms
		2. TENS - 0.064 Watt/cm² @ Load of 500 Ohms
		3. EMS - 0.064 Watt/cm² @ Load of 500 Ohms
11.	Treatment Time	1 - 100 MINUTES

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TRADITIONAL 510(K)

ANNEXURE 'VIII'

INTENDED USE:

Tone-A-Matic is indicated to be used for

Russian and EMS for:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy .
. Increase local blood circulation
Muscle re-education .
. Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

L TENS for:

Symptomatic relief of chronic, intractable pain. .
· Management of pain associated with post-traumatic or post-operative conditions.

SUBSTANTIAL EQUIVALENCE:

The electrical stimulation provided by the Tone-A-Matic device is similar to that of Predicate Device Winstim. The electrical pulses transmitted in different modes are restricted in amplitude and duration to values consistent with that of the predicate device quoted above in electrical parameter comparisons. User safety has been taken into account while designing the Tone-A-Matic device.

The differences that exist between these devices are insignificant in the terms of safety or effectiveness.

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TRADITIONAL 510(K)

NON-CLINICAL TESTS PERFORMED:

Tone-A-Matic complies with international standards for electrical safety and electromagnetic compatibility. Compliance to applicable voluntary standards includes IEC 60601-1. Ed3.0, IEC 60601-1-2, IEC 60601-2-10,IEC 60601-1-11 and ISO 14971: 2007. Comprehensive risk analysis has been carried out for the device with regards to safety and effectiveness. Addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

CONCLUSION:

The electrical stimulation provided by the Tone-A-Matic device is similar to that of Predicate Device Winstim.

The Tone-A-Matic has same intended use and similar technological characteristics as its FDA cleared predicate devices. Moreover the verification and validation tests contained in this submission demonstrate that the differences in the Tone-A-Matic still maintain the same safety and effectiveness as that of the cleared predicate. In other words, those enqineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Safety concerns regarding proper use of electrodes and electrode pads placement have been fully addressed by making the user conscious of the proper placement of electrodes and proper operations of the device through detail in the User's Instruction Manual.

Material Used in Tone-A-Matic Device which will come in contact with the patient

l) Enclosure Made up of ABS Material
1. Lead wire Made up of PVC material
1. Electrodes : 2" X 2" square self adhesive 510(K) cleared , K002227

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle symbol, represented by three curved lines that suggest the wings and body of the bird.

Public Health Service

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

Johari Digital Healthcare, Ltd. % Ms. Nisha Johari Electronic Hardware Technology Park G-582,583, E.P.I.P., Boranda Jodhpur, Rajasthan, 342008 India

MAR 1 7 201

Re: K102190

Trade/Device Name: WinStim Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, GZJ, IPF, GZI Dated: February 14, 2011 Received: February 14, 2011

Dear Ms. Johari:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may; therefore, market the device subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

{9}------------------------------------------------

Page 2 - Ms. Nisha Johari

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K102190
page 1 of 1

Indications for Use

510(k) Number (if known): K102190

Device Name: WinStim

Indications For Use:

Q Russian and High Volt and EMS for:

. Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increase local blood circulation ●
. Muscle re-education
Maintaining or increasing range of motion ●
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. .

0 Interferential, Premod and TENS for:

· Symptomatic relief of chronic, intractable pain.
· Management of pain associated with post-traumatic or post-operative conditions.

Q Ultrasound for:

Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:

Pain Relief
Reduction of muscle spasms .
· Joint contractures

Prescription Use V (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)

Kandall R. Eager

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K102190

Regulation Number and Section

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.