WINSTIM

K102190 · Johari Digital Healthcare , Ltd. · IMG · Mar 17, 2011 · Physical Medicine

Device Facts

• Record ID: K102190
• Device Name: WINSTIM
• Applicant: Johari Digital Healthcare , Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Mar 17, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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. TENS for: Symptomatic relief of chronic, intractable pain. . Management of pain associated with post-traumatic or post-operative conditions.

Device Story

Tone-A-Matic is a portable, micro-controller-operated powered muscle stimulator and TENS device. It generates pre-programmed electrical impulses (Russian, TENS, EMS modes) delivered via adhesive electrode pads to specific body areas. The device features an LCD screen for monitoring treatment mode, countdown timer, and battery status; intensity is adjusted via keypads. It is intended for clinical use by healthcare professionals to treat multiple body areas simultaneously. By delivering controlled electrical stimulation, the device aims to relax muscle spasms, prevent atrophy, improve circulation, re-educate muscles, maintain range of motion, and manage pain. It is powered by a 24 VDC adapter or rechargeable battery, allowing for mobility in clinical settings.

Clinical Evidence

Bench testing only. The submission relies on performance testing, including electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11), software verification, and risk analysis (ISO 14971) to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Portable micro-controller-based stimulator; 24 VDC adapter or rechargeable battery power. Enclosure: ABS; Lead wires: PVC. Electrodes: 2"x2" self-adhesive. Output: 8 channels, synchronous. Waveforms: Square wave (Russian, TENS, EMS). Connectivity: Standalone. Sterilization: Not applicable (non-sterile). Software: Micro-controller firmware.

Indications for Use

Indicated for patients requiring muscle stimulation for spasm relaxation, disuse atrophy prevention, blood circulation improvement, muscle re-education, range of motion maintenance, or post-surgical venous thrombosis prevention; and for patients requiring TENS for symptomatic relief of chronic, intractable pain or management of post-traumatic/post-operative pain.

Regulatory Classification

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.

Predicate Devices

• Winstim (K102190)

Submission Summary (Full Text)

{0}------------------------------------------------

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 | : [e-mail] |
| Phone | : [phone] |
| Fax | : [phone] |
| 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

{1}------------------------------------------------

#### NEW DEVICE FOR WHICH SUBMITTING

| Common or Usual Name | :POWERED MUSCLE STIMULATOR.<br>MUSCLE STIMULATOR<br>TRANSCUTANEOUS ELECTRICAL NERVE<br>STIMULATION FOR PAIN RELIEF |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name | : Powered muscle stimulator<br>(21 CFR 890.5850, Product Code IPF)<br>And<br>Transcutaneous electrical nerve stimulator for pain<br>(21 CFR 882.5890, Product Code GZJ) |
| Trade Name | :Tone-A-Matic |
| Model Name of Device | :TDB 68 |

| LEGALLY MARKETED DEVICE<br>Winstim | : Ultrasound and Powered Muscle Stimulator |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | : Ultrasound and Muscle stimulator |
| 510(k) Number : | : K102190 |
| Manufacturer<br>Address | :Johari Digital Healthcare Ltd.<br>:Electronic Hardware Technology Park<br>G-582, 583,E.P.I.P., Boranada<br>Jodhpur (Rajasthan)-342008<br>INDIA |

#### DESCRIPTION OF NEW DEVICE Tone-A-Matic

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

#### 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.

{4}------------------------------------------------

# 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 Wave<br>2. TENS - Square Wave<br>3. EMS - Square Wave |
| 3. | Maximum Output<br>Voltage | 1. RUSSIAN -<br>50 Vpp @ 500Ω<br>60Vpp @2KΩ<br>2. TENS -<br>57 Vpp @ 500Ω<br>90Vpp @2KΩ<br>3. EMS -<br>57 Vpp @ 500Ω<br>90Vpp @2KΩ |
| 4. | Maximum Output<br>Current | 1. RUSSIAN -<br>100 mA pp @ 500Ω<br>30mA pp @ 2KΩ<br>2. TENS -<br>114 mA @ 500Ω<br>45mA pp @ 2KΩ<br>3. EMS -<br>114 mA pp @ 500Ω<br>45mA pp @ 2KΩ |
| 5. | Number Of Output | 8 |
| 6. | Number of Output<br>Channels Synchronous<br>or Alternating? | Synchronous<br>(a) Channel 1 and 2 are completely isolated. Only<br>power supply and ground are common<br>Confirms to ANSI 3.2.3.2 |
| 7. | Net Charge | 1. RUSSIAN - 0 μC<br>2. TENS - 0 μC<br>3. EMS - 0 μC |
| 8. | Maximum Phase Charge | 1. RUSSIAN - 20.00 μC<br>2. TENS - 22.5 μC<br>3. EMS - 22.5 μC |
| 9. | Maximum Current<br>density | 1. RUSSIAN - 3.87 mA/cm2 @ Load of 500 Ohm<br>2. TENS - 4.41 mA / cm2 @ Load of 500 Ohm<br>3. EMS - 4.41 mA / cm2 @ Load of 500 Ohm |
| 10. | Maximum Power Density | 1. RUSSIAN - 0.193 Watt/cm2 @ Load of 500 ohm<br>2. TENS - 0.251 Watt / cm2 @ Load of 500 Ω<br>3. EMS - 0.251 Watt / cm2 @ Load of 500 Ω |
| 11. | Treatment Time | 1 - 60 MINUTES |

{5}------------------------------------------------

# 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 - Sinusoidal<br>2. TENS - Square Wave<br>3. EMS - Square Wave |
| 3. | Maximum Output<br>Voltage | 1. RUSSIAN -<br>50 Vpp @ 500Ω<br>2. TENS -<br>57 Vpp @ 500Ω<br>225 Vpp @ 2KΩ<br>3. EMS -<br>57 Vpp @ 500Ω<br>225 Vpp @ 2KΩ |
| 4. | Maximum Output<br>Current | 1. RUSSIAN -<br>100 mA @ 500Ω<br>2. TENS -<br>114 mA @ 500Ω<br>112.5 mA @ 2KΩ<br>3. EMS -<br>114 mA pp @ 500Ω<br>112.5 mA @ 2KΩ |
| 5. | Number Of Output<br>Modes | 7 |
| 6. | Number of Output<br>Channels Synchronous<br>or Alternating? | Synchronous<br>(a) Channel 1 and 2 are completely isolated. Only<br>power supply and ground are common<br>(b) Electrotherapy and Ultrasound are also isolated.<br>They have their own Hardware, which are<br>completely isolated. Confirms to ANSI 3.2.3.2 |
| 7. | Net Charge | 1. RUSSIAN - 0 µC<br>2. TENS - 0 µC<br>3. 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 Current<br>density | 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 |

{6}------------------------------------------------

### 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.

{7}------------------------------------------------

#### 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
- 2) Lead wire Made up of PVC material
- 3) Electrodes : 2" X 2" square self adhesive 510(K) cleared , K002227

{8}------------------------------------------------

## 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 [phone] or [phone] 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

{10}------------------------------------------------

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