TENSCARE ITOUCH MODEL(S) EASY AND PLUS

K082377 · Tenscare, Ltd. · GZJ · Feb 9, 2009 · Neurology

Device Facts

• Record ID: K082377
• Device Name: TENSCARE ITOUCH MODEL(S) EASY AND PLUS
• Applicant: Tenscare, Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Feb 9, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS stands for Transcutaneous Electrical Nerve Stimulation. The itouch TENS system is indicated for: Symptomatic relief and management of chronic, intractable pain. Adjunctive treatment for post-surgical and post-trauma acute pain.

Device Story

Portable TENS device for pain relief; provides transcutaneous electrical nerve stimulation via dual isolated output channels. User adjusts frequency, pulse width, and timing parameters via LCD interface. Features 9 modes, timer, and doctor lock/unlock facility. Operates on 2 AA alkaline batteries. Incorporates constant current output (active in 500Ω–1500Ω load range) for safety; includes open circuit detectors. Used in clinical or home settings; operated by patients or clinicians. Output affects pain management through electrical stimulation. Non-volatile memory stores settings.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by compliance with recognized international consensus standards, risk analysis, FMEA, and post-market performance data from European marketing experience.

Technological Characteristics

Portable digital TENS unit; dual isolated output channels; LCD display; 2 AA alkaline batteries. Constant current output (500Ω–1500Ω load range). Non-volatile memory. Open circuit detection. Complies with recognized international consensus standards for safety and effectiveness.

Indications for Use

Indicated for symptomatic relief and management of chronic, intractable pain and as adjunctive treatment for post-surgical and post-trauma acute pain in patients requiring TENS therapy.

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

• EasyMed TENS Unit TN-28C (K040253)
• Gemore GM300T (K032720)

Submission Summary (Full Text)

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

K0r2377

FEB - 9 2009

# 510(k) Summary

-- 4 --

Date of Summary prepared: January 21, 2005

Submitter: Tenscare Ltd

9 Blenheim Road, Longmead Business Park, Epsom, Surrey, KT19 9BE, Address : United Kingdom

Tel [phone] .

Fax [phone]

E-Mail [e-mail] :

Contact person: Anthony Jankel

Address of the manufacturing facility:

EasyMed Instrument Ltd 3/F, No.2 Bei Hai Da Road, Lun Jiao, Shun De, Guang Dong, China. Zip: 528308

Address of American Representative: DEBORAH IAMPIETRO QRC CONSULTING ASSOCIATES 130 gotzens rd

conway, NH 03818 Phone: [phone] ext Fax: [phone]

Email: [e-mail]

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

### Submitted Device:

Generic name: Transcutaneous Electrical Nerve Stimulator (TENS) Tenscare itouch Trade name: Common name: TENS device Classification name: Stimulator, Nerve, Transcutaneous, for Pain Relief - GZJ; 21 CFR 882.5890. Device Classification: Class II Predicate Devices: EasyMed TENS Unit TN-28C (K040253) Gemore GM300T (K032720) (http://www.gemore.com.tw/) The class of the predicate Devices: Class II Device Description: A portable TENS device for pain relief.

Features:

- · Innovative design
- · Large LCD display
- · Dual output isolated channels
- · 2 AA Alkaline Batteries
- · Adjustable frequency, pulse width, and timing parameters
- 9 different modes
- · Timer option
- · Doctor lock/unlock facility
- · Open circuit detectors
- · Non-volatile

The intended use of the device:

TENS stands for Transcutaneous Electrical Nerve Stimulation. The itouch TENS system is indicated for:

- Symptomatic relief and management of chronic, intractable pain. .
- Adjunctive treatment for post-surgical and post-trauma acute pain. .

The intended use and indications for use of the new device are very similar to that of the predicate devices.

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

Technological Comparison:

- 1. The marketed device EasyMed TN-28C (K040253) is a digital TENS unit which has been well exploited the digital technology, supplying the user with full ranges of parameters, traditional TENS functions, and non-traditional new functions to be selected.
- 2. The designed circuitry of new device itouch is very similar to the marketed device TN-28C, they are of similar circuit diagrams and similar working principle; The main difference between the two devices is that TN-28C is not a constant current TENS device while itouch is a constant current device.
- 3. Both itouch and TN-28C (K040253) are passed the same tests of applicable recognized international consensus standards.
- 4. The marketed device Gemore GM300T (K032720) is a TENS device with constant current output. The specification of GM300T is very similar with that of itouch.
- 5. The new device itouch is of the same range of parameters as those of marketed devices.
- 6. Itouch was designed and added the constant current feature based on the design of TN-28C (K040253). The introduction of marketed device Gemore GM300T (K032720) is for the purpose of comparison of the feature of constant current.
- 7. The accessories of the new device itouch are similar to those of the marketed devices.

Labelling Comparison: The Labelling is substantially equivalent to that of the predicate devices.

Safety information:

Design to comply with relevant safety applicable recognized consensus standards; the output energy is well controlled in the safety and effectiveness ranges specified by relevant FDA guidance's. Testing has been carried out in very detailed and strictly. Test results, Risk Analysis, and FMEA analysis show that the new unit itouch is safe with no any hazard.

itouch has been marketed in Europe. During this period a review of Customer Complaints, Returned Product and the results of Post Market Feedback, has demonstrated that the product has performed

-- ( --

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

as Intended, to its' Specified Requirements.

It is the first submission to FDA for this new device

The new device itouch is of the feature of constant current. But this feature is only applied in the range of load from 500Ω to 1500Ω, the current is being get down and tends to zero when the load is being get far from this range, this character makes the device safe reliably.

Submitted times:

Conclusions:

Important remark:

The itouch TENS unit is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.

There are two models for Tenscare itouch TENS devices: "Easy" and "Plus". Because all functions of "Easy" can be covered by "Plus" (see instruction manual in Section V), we do not discuss "Easy" model in this submission and consider it as no significant change.

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tenscare Ltd % Mr. Anthony Jankel 9 Blenheim Road Longmead Business Park, Epsom Surrey, KT19 9BE United Kingdom

Re: K082377

Trade Name: Tenscare TENS Model itouch Regulation Number: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: December 12, 2008 Received: December 12, 2008

FEB - 9 2009

Dear Mr. Jankel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 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); 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.

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

Page 2 - Mr. Anthony Jankel

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 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 toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N Millerson

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

Enclosure

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

510(k) Number (if known):

Device Name

Tenscare TENS Model itouch

## Indications for Use

TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is indicated for:

- Symptomatic relief and management of chronic, intractable pain. .
- Adjunctive treatment for post-surgical and post-trauma acute pain.

Prescription Use × (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)

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

-- 9 --

510(k) Number