· 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.

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

Here's an analysis of the provided text regarding the Acceptance Criteria and Study to prove the device's adherence:

Based on the provided 510(k) Summary for the Tone-A-Matic device, there is a fundamental misunderstanding in your request. A 510(k) submission for this type of device (Powered Muscle Stimulator / TENS) does not typically involve the kind of acceptance criteria, clinical studies with ground truth established by experts, or MRMC comparative effectiveness studies that you are asking about.

This document is a Premarket Notification (510(k)), which demonstrates "substantial equivalence" to a legally marketed predicate device, not necessarily proof of meeting performance acceptance criteria from a clinical study in the way you've outlined for an AI/CAD-type device.

Therefore, I cannot fill out your requested table and information points as they pertain to a different type of medical device evaluation. Instead, I will describe the approach used in this 510(k) submission to demonstrate equivalence, which relies heavily on non-clinical tests and direct comparison of technical specifications and intended use.

Explanation of TONE-A-MATIC 510(k) Submission Approach

The Tone-A-Matic device is a Powered Muscle Stimulator and Transcutaneous Electrical Nerve Stimulator (TENS). For devices like this, the demonstration of safety and effectiveness for a 510(k) clearance typically involves showing that the new device is substantially equivalent to a legally marketed predicate device in terms of:

Intended Use: The new device is intended for the same uses as the predicate.
Technological Characteristics: The new device has technological characteristics that are similar to the predicate, or if they are different, the differences do not raise new questions of safety or effectiveness.

The provided document does not contain information about clinical studies with human readers, ground truth established by experts, or AI performance metrics because such studies are generally not required for this type of device to demonstrate substantial equivalence.

The "proof" the device meets acceptance criteria is primarily through:

Comparison of Technical Specifications: Directly comparing the electrical output parameters (voltage, current, waveform, net charge, phase charge, current density, power density) of the new device to the predicate device.
Compliance with Recognized Standards: Demonstrating adherence to relevant electrical safety and electromagnetic compatibility standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971).
Software Verification: If applicable, verification activities for embedded software (though the summary states "software verification has been carried out," specific details are not provided beyond adherence to FDA guidance).
Risk Analysis: A comprehensive risk analysis to address safety and effectiveness concerns.

Re-interpretation for the Context of the Provided Document

Given the nature of the provided document, here's how I can address your request, acknowledging that the criteria and studies described are for substantial equivalence rather than the clinical performance metrics you've requested for an AI/CAD device.

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" here are points of comparison to the predicate device that demonstrate substantial equivalence. The "reported device performance" is the comparison against the predicate's specifications and the device's compliance with safety standards.

Acceptance Criterion (Basis for Substantial Equivalence)	Reported Device Performance (as compared to Predicate Device Winstim, K102190)
Intended Use Equivalence: Same indications for use (Russian/EMS & TENS modes).	Met: The Tone-A-Matic has the exact same listed indications for use as the predicate device Winstim for both Russian/EMS (relaxation of muscle spasms, prevention of disuse atrophy, increase local blood circulation, muscle re-education, maintaining/increasing range of motion, immediate postsurgical stimulation of calf muscles) and TENS (symptomatic relief of chronic, intractable pain, management of pain associated with post-traumatic or post-operative conditions).
Technological Characteristics Equivalence (General): Similar design & functionality.	Met: Both are micro-controller operated, non-transit-operable, portable devices that generate electrical impulses. Both have user-friendly interfaces with LCDs, adjustable intensity, and treatment timers. The Tone-A-Matic is light weight, small, and battery-powered, similar to the predicate's portable nature. Accessories provided are of "same quality and standards" as the predicate.
Technical Specifications (Electrical Output): Comparable waveform, voltage, current, charge, density.	Met/Justified as Equivalent: While there are some differences, the document asserts these are "insignificant in the terms of safety or effectiveness."- Waveform: Tone-A-Matic uses Square Wave for all 3 modes; Winstim uses Sinusoidal for Russian and Square Wave for TENS/EMS. (This difference is deemed acceptable, likely due to similar physiological effect or within acceptable electrical safety limits).- Max Output Voltage: Tone-A-Matic: Russian 50Vpp@500Ω, 60Vpp@2KΩ; TENS/EMS 57Vpp@500Ω, 90Vpp@2KΩ. Winstim: Russian 50Vpp@500Ω; TENS/EMS 57Vpp@500Ω, 225Vpp@2KΩ. (Tone-A-Matic's 2KΩ TENS/EMS voltage is lower, which would be safer, not raising new safety questions).- Max Output Current: Tone-A-Matic: Russian 100mA@500Ω, 30mA@2KΩ; TENS/EMS 114mA@500Ω, 45mA@2KΩ. Winstim: Russian 100mA@500Ω; TENS/EMS 114mA@500Ω, 112.5mA@2KΩ. (Tone-A-Matic's 2KΩ TENS/EMS current is lower, implying safety).- Net Charge: Both 0µC for all modes.- Maximum Phase Charge: Both 20/22.5µC for respective modes.- Max Current Density: Similar values for both devices.- Max Power Density: Tone-A-Matic provides specific values for all modes; Winstim shows some differences, but these are likely considered within acceptable limits for equivalence (e.g., Tone-A-Matic TENS/EMS 0.251 W/cm² vs Winstim TENS/EMS 0.064 W/cm² - if the higher value is still safe, it's considered equivalent).- Treatment Time: Tone-A-Matic (1-60 min) vs Winstim (1-100 min). (The shorter maximum duration would also be considered safe).- Number of Output: Tone-A-Matic: 8; Winstim: not specified but implies multiple channels.
Electrical Safety and EMC Compliance: Conformity to international standards.	Met: Tone-A-Matic complies with IEC 60601-1 (Ed3.0), IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and ISO 14971:2007.
Software Verification: Compliance with FDA guidance.	Met: Software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (No specific test results are detailed in this summary).
Risk Analysis: Comprehensive analysis carried out.	Met: A comprehensive risk analysis has been carried out regarding safety and effectiveness. (No specific details provided in this summary).

Regarding the other information points, these are not applicable to the provided 510(k) submission for a non-AI/CAD device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as this is a comparison to a predicate device based on technical specifications and standards compliance, not a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There's no "ground truth" establishment by experts in the context of a diagnostic dataset for this submission. The "ground truth" for the device's performance is its adherence to internal specifications and relevant safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 is not an AI/CAD diagnostic device.

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

Not applicable. This is not an AI device.

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

Not applicable in the AI/CAD sense. The "ground truth" for this device's safety and effectiveness relies on its measured electrical output parameters aligning with specified ranges and its design conforming to established national and international safety standards.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no training set.

9. How the ground truth for the training set was established

Not applicable.

In summary, the Tone-A-Matic 510(k) submission successfully demonstrated substantial equivalence to its predicate device, Winstim, through a detailed comparison of its intended use, technological characteristics, and technical specifications, alongside compliance with relevant safety and performance standards. It did so without conducting the types of clinical studies involving expert readers, ground truth establishment through consensus/pathology, or AI performance metrics as typically seen for AI/CAD devices.

Summary

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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	: toneamaticint@gmail.com
Phone	: +1-905-501-0457
Fax	: +1-905-501-9290
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.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	:TDR 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

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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

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 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 pp @ 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
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 - 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 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
1. Lead wire Made up of PVC material
1. 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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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/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 (800) 638-2041 or (301) 796-7100 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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).