THERAPEUTIC MASSAGE COMPANION

K060846 · Endurance Therapeutics · NUH · Dec 3, 2007 · Neurology

Device Facts

• Record ID: K060846
• Device Name: THERAPEUTIC MASSAGE COMPANION
• Applicant: Endurance Therapeutics
• Product Code: NUH · Neurology
• Decision Date: Dec 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K060846 · Dec 3, 2007	THERAPEUTIC MASSAGE COMPANION	Endurance Therapeutics	Postmarket surveillance data (sales and adverse event reporting); Peer-reviewed clinical literature	The sponsor utilized postmarket surveillance data from 300,000 units sold over 5 years to demonstrate safety and cited peer-reviewed literature to support the effectiveness of electrical stimulation for pain relief and muscle performance.	Postmarket surveillance; Adverse event reporting; Literature review

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Postmarket Surveillance Data; Postmarket surveillance / Real-world usage data; Follow-up/Duration: 2002-2007 (5 years); Study Period: 2002-2007	General population (300,000 units sold); Sample Size: 300,000 units	Not applicable for this study	Safety (adverse event reporting)
Peer-reviewed literature review; Literature review	Patients undergoing electrical stimulation	Not applicable for this study	Muscle performance improvement and temporary pain reduction

Indications for Use

To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4 To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3 To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto 4 Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2

Device Story

T1040 is a portable, battery-powered (4.5 VDC) TENS and Powered Muscle Stimulator (PMS). Device delivers preprogrammed electrical pulses via two electrode pads attached to a garment belt or directly to skin. User selects from 10 operation modes (6 manual, 4 automatic) to induce minimal muscle contractions. Operated by patient in home setting without medical supervision. Output consists of electrical stimulation pulses; intended to provide temporary pain relief and improve muscle performance. Clinical benefit supported by historical sales data and peer-reviewed literature on electrical stimulation.

Clinical Evidence

No clinical trials performed. Evidence based on historical performance (300,000+ units sold globally since 2002 with no reported adverse events) and literature review supporting electrical stimulation for pain reduction and muscle performance.

Technological Characteristics

Portable, battery-powered (4.5 VDC) TENS/PMS device. Dual-channel output via adhesive electrode pads. Compliance with AAMI NS-4 1985, EN 60601-1, EN 60601-1-2, ISO 9001:2000, ISO 13485:2003. Pulse width 210 µs, max frequency 245 Hz.

Indications for Use

Indicated for temporary relief of pain in lower back, upper extremities, and lower extremities due to exercise or household strain; also indicated for stimulation of healthy muscles to improve/facilitate performance. For OTC use.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Compex Sport Muscle Stimulator (K011880)
• Prizm Medical inc. 5000Z OTC TENS Back Pain Relief System (K033122)
• Bio Stim Kit (K050174)

Submission Summary (Full Text)

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

510k: T1040 Endurance Therapeutics

K060846

# 510(k) Summary

This 510(k) summary is being submitted in accordance with 21 CFR 807.92(c)

### 1.0 Submitter's Name and Address:

Endurance Therapeutics 122B First Street, NE Dauphin, Manitoba Canada R7N 1B5

Contact Name: Brad Brezden 122B First Street, NE Dauphin, Manitoba Ph. / Fax [phone]

DEC 0 3 2007

Date Prepared: August 27, 2007

## 2.0 Name of Device and Classifications

Trade/Device Name: T1040: Common Name: TENS Regulation Number: 21 CFR 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter. Requlatory Class: Class II Product Code NUH, NGX, GZJ

## 3.0 Predicate Devices

K011880 Compex Sport K033122 Prizm Medical inc. K050174 Bio Stim Kit,

Sport Muscle Stimulator 5000Z OTC TENS Back Pain Relief System 21CFR890.5850 OTC 21CFR882,5890 OTC 21CFR882.5890 OTC

## 4.0 Device Description:

The T1040 is a portable; battery powered (4.5 VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.

Independent channel (two pads) that effectively transfers your desired choice of preprogrammed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. A garment belt is used to hold the electrode pads to treat the lower back muscles. There are 10 modes of operation, 6 manual and 4 automatic.

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

| Quantity | T1040 | Bio-Stim | Compex | 5000Z |
|-------------------------------------------------|-----------|----------|-------------|-------|
| Max. Voltage over 10kΩ, V | 154.1 | 132 | 126.8/103.3 | 226 |
| Max. Current over 10kΩ, mA | 15.4 | 13.2 | 12.7/10.3 | 22.6 |
| Max. Voltage over 2.2kΩ, V | 105.1 | 90 | 167.8/153.5 | 218 |
| Max. Current over 2.2kΩ, mA | 47.8 | 41 | 76.3/69.8 | 99 |
| Max. Voltage over 500Ω, V | 40.7 | 29.5 | 48 | 208 |
| Max. Current over 500Ω, mA | 81.4 | 59 | 96.1 | 416 |
| Pulse Width, µseconds | 210 | 30 - 225 | 270 | 100 |
| Pulse Period, msec | 4.1 - 500 | 9 – 12.5 | 125 | 10 |
| Max. Pulse Frequency, Hz | 245 | 110 | 118 | 120 |
| Max. Charge per Phase over 500Ω,<br>μC | 16.9 | 7.6 | 32.3 | 3.4 |
| Max. Current Density over 500Ω,<br>mA/cm² | 2.71 | 3.93 | 3.84 | 16.64 |
| Max. Average Power Density over<br>500Ω, mW/cm² | 5.35 | 1.1 | 10.2 | |

Table 14 - Comparison Table

## Electrical Parameter Comparisons

Intended Use:

5.0

To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto 4

ls intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2

## 6.0 Substantial Equivalence:

The electrical stimulation provided by the T1040 is substantially equivalent to that commonly employed by muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling; i.e., for OTC sale. The pulses in the waveform combinations are restricted in amplitude and duration to values consistent with other devices quoted above.(see Appendix 4)

Technological characteristics, features, specifications, materials and intended uses of the T1040 are substantially equivalent to the quoted predicate devices.

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

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

The T1040 has modes that offer substantially equivalent technical specifications, features and effective results as each of the predicates listed.

## 7.0 Non-Clinical Tests Performed:

Compliance to applicable voluntary standards includes AAMI NS-4 1985, as well as EN 60601-1, EN 60601-1-2, ISO 9001;2000 and ISO 13485;2003

In 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.

## 8.0 Conclusion:

The electrical stimulation provided by the T1040 is similar to that commonly employed by muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling.

The T1040 has the same intended uses and the similar technological characteristics as these OTC cleared predicates. Moreover, verification and validation tests contained in this submission demonstrate that the differences in the T1040 still maintain the same safety and effectiveness as that of the cleared devices.

In other words, those engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Concerns of safe and proper use of electrodes and electrode pad placements 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.

We believe that there are no new safety or effectiveness issues concerning this device to be introduced.

The safety of the device, to be used for the proposed indications without medical prescription or supervision, is established by the fact that no adverse events have been reported since 2002 with over 300,000 units sold with out a prescription in 20 countries.

Over 300 000 units sold with no adverse effects reported, proves its specific technical, safety measures and features are safe and effective when used without medical supervision. An even greater and more detailed user instruction manual regarding safe operation and adhesive pad placements is proposed for the USA marketplace and consumers.

The effectiveness of the device for the proposed indications is supported by a number of articles in peer-reviewed publications, which demonstrate that electrical stimulation does improve muscle performance as well as temporary pain reduction.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2007

Endurance Therapeutics % Mr. Brad Brezden CEO 122 B - First Street, NE Dauphin, Manitoba, Canada R7N IBS

Re: K060846 Trade/Device Name: T1040 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH, NGX Dated: August 27, 2007 Received: September 4, 2007

Dear Mr. Brezden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use bland in the encreations of the enactment date of the Medical Device Amendments, or to conimer of pror to may 2011-07-12) 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 r ou may, dierelove, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such 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 r tease of acrised and itermination that your device complies with other requirements of the Act that I Drivias Intact and regulations administered by other Federal agencies. You must or uny I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It rat 8077, accems (21 (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.

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

Page 2 - Mr. Brad Brezden

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## 13.0 Statement of Indication for Use

510(k) Number (if known): K060846

Device Name: T1040

Indications for Use:

To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto 4

Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter 1150 AND/OR (21 CFR 801 Subpart C

XX

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence

Division of General. Restorative. and Neurological Devices

5100) Number Kolo yu