TONE-A-MATIC

K130052 · Tone-A-Matic International, Inc. · IPF · Dec 20, 2013 · Physical Medicine

Device Facts

• Record ID: K130052
• Device Name: TONE-A-MATIC
• Applicant: Tone-A-Matic International, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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. 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; not for patient wear. Device generates pre-programmed electrical impulses (Russian, TENS, EMS modes) delivered via adhesive electrode pads to target body areas. Operated by clinicians in a clinical setting; user interface includes LCD screen, keypad for intensity adjustment, and treatment timer (1-60 min). Device allows simultaneous treatment of different body areas. Output parameters are controlled to match predicate device performance. Clinical benefit includes pain management, muscle rehabilitation, and prevention of post-surgical complications. Device is battery-powered or AC-adapter operated.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and ISO 14971:2007 standards confirmed. Software verification performed per FDA guidance.

Technological Characteristics

Micro-controller-based stimulator; 8 synchronous output channels. Waveforms: Square (TENS, EMS), Square (Russian). Power: 24 VDC/battery. Materials: ABS enclosure, PVC lead wires, 2"x2" self-adhesive electrodes. Dimensions: 10.3" x 7.5" x 3.5"; Weight: 1.78 kg. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, ISO 14971.

Indications for Use

Indicated for patients requiring muscle stimulation (Russian/EMS) for spasm relaxation, disuse atrophy prevention, blood circulation, 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

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.

Predicate Devices

• Winstim (K102190)

Reference Devices

• K050469
• K002227

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Tone-A-Matic International Incorporated. The logo is in black and white and features a stylized font. The words "Tone-A-Matic" are in large, bold letters, with the "T" in "Tone" having a unique design. Below the main text, the words "International Incorporated" are written in a smaller font, underlined by a thin line.

### 510(k) Summary

| Submitter's Name | : TONE-A-MATIC INTERNATIONAL INC |
|----------------------------|----------------------------------|
| Contact person | : Ms. ANNIA KORDIUK |
| E-mail | : [e-mail] |
| Phone | : [phone] |
| Fax | : [phone] |
| Date of Summary Submission | : April 28, 2014 |
| Resubmitting on. | : N.A. |

C. Aianaftefraine

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

145 TRADERS BLVD. E. UHT 18, NISS 905-501-9290

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#### 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 | :TDR 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.

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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:

- 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

- 0
#### 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.

#### ப 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 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 pp @ 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 |
| The Call of the Children Children of the Children of the Children of the Children of the Children of the Children of the Children of the Children the Children the Children th | Treatment Time | - 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 - 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 μC |
| | | 3. EMS - 22.5 μC |
| 9. | Maximum Current 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 |

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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.

#### 0 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
- 2) Lead wire Made up of PVC material
- 3) Electrodes : 2" X 2" square self adhesive 510(K) cleared , K002227

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Image /page/8/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter of the circle. The text is in all capital letters and is arranged to follow the curve of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### December 20, 2013

TONE-A-MATIC INTERNATIONAL INC. Ms. Annia Kordiuk Operations Manager 145 Traders Blvd. E Unit 18 Mississauga, Ontario L4Z 3L3 CANADA

Re: K130052

. ·

Trade/Device Name: Tone-A-Matic Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: November 15, 2013 November 19, 2013 Received:

Dear Ms. Kordiuk:

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 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

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Page 2 - Ms. Annia Kordiuk

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Joyce M. Whang -S

for Carlos L. Peña. Ph.D. 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): K130052

Device Name: Tone-A-Matic

Indications For Use:

ﻪ ﻋﻘﺐ ﺍﻟﻌﻤﻞ ﺍﻟﻤﻮﺿﻮﻋﻴﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺴ

Tone-A-Matic is indicated to be used for

- · Russian and EMS for:
- o Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy o
- Increase local blood circulation o
- Muscle re-education o
- Maintaining or increasing range of motion o
- Immediate postsurgical stimulation of calf muscles to prevent venous 0 thrombosis.
- TENS for: ●
- Symptomatic relief of chronic, intractable pain. o
- o Management of pain associated with post-traumatic or post-operative conditions.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) · .

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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