TENS STIMULATOR, MODELS 2800 AND 3000

K102014 · Koalaty Products, Inc. · GZJ · Aug 31, 2010 · Neurology

Device Facts

• Record ID: K102014
• Device Name: TENS STIMULATOR, MODELS 2800 AND 3000
• Applicant: Koalaty Products, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

Device Story

TENS 2800 and TENS 3000 are portable, battery-operated transcutaneous electrical nerve stimulators for pain relief. Device delivers electrical current to nerves via skin-surface electrodes and lead wires. User adjusts intensity and treatment mode (normal, burst, or modulation) using manual rotate buttons and switches. Device housed in molded plastic case with battery compartment. Intended for use by patients to manage pain; output parameters (pulse width, frequency) controlled by internal circuitry. Healthcare providers use device to provide non-invasive pain management, potentially reducing reliance on pharmacological interventions. Device provides symptomatic relief; does not treat underlying pathology.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing and adherence to voluntary safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10).

Technological Characteristics

Portable TENS stimulator; 9V battery powered; ABS plastic enclosure (UL approved). Output: 2 channels, voltage-controlled, biphasic or monophasic rectangular pulses. Frequency: 2-150Hz; Pulse width: 30-260us. Connectivity: None. Sterilization: N/A (non-sterile). Microprocessor-controlled parameters.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post surgical pain in patients requiring transcutaneous electrical nerve stimulation.

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

• LT3001 TENS Stimulator (K100117)

Submission Summary (Full Text)

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\$\qquad 510(k):\$

KOALATY PRODUCTS, INC.
A Current Solutions Company

File No: WMI-04-TENS -FDA-05 Version: 1.1

AUG 3 1 2010

# 510(k) SUMMARY

TENS Electro-Stimulator, K(102014 )

4/15/2010 Date of Submission:

Koalaty Products.,INC 510(k) Submitter's Name:

> 3814 Woodbury Dr Austin TX 78704 Address:

510(k) Correspondent contact: Kang Jian Ping [e-mail] E-mail: Telephone: [phone] [phone] Fax:

Section 05-Page 1 of 4

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Image /page/1/Picture/0 description: The image shows the logo for KoalaTY Products, INC. The logo features a stylized image of a koala's head on the left. To the right of the koala image, the text "KoalaTY Products, INC." is written in a simple, sans-serif font. Below the company name, the text "A Current Solutions Company" is written in a smaller font.

File No: WMI-04-TENS -FDA-05 Version: 1.0

#### 1. Proposed Device:

Trade Name: TENS 2800 Stimulator TENS 3000 Stimulator Classification Name: Stimulator, Nerve, Transcutaneous. For pain relief Regulation Number: 882.5890 Product Code: GZJ Device Class: ||

#### 2. Predicate Device:

Predicate Device: LT3001 TENS Stimulator 510(k) Number: K100117 Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.

#### Description of Proposed Device: 3.

TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.

These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No.

TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.

#### Proposed Device Intended Use Statement: 4.

Device Name:

TENS 2800 Stimulator, TENS 3000 Stimulator

### Indications for Use:

- Symptomatic relief of chronic intractable pain, 1)
- Post traumatic pain 2)
- Post surgical pain 3)

Section 05-Page 2 of 4

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KOALATY PRODUCTS, INC.
A Current Solutions Company

File No: WMI-04-TENS -FDA-05 Version: 1.0

#### 5. Biocompatibility Certification:

Electrodes to be provided with this device are from the manufacturer Top-Rank Health Care Equipment Co., Ltd (K070612) who submitted in 2007.

The shell of device is used ABS material; this material has passed Biocompatibility testing in Jiangsu TUV Product Service Ltd. Shanghai Branch. Identification No: 080960.

#### 6. Technological Characteristics and Substantial Equivalence

Both the TENS Series Electro-Stimulator and the Predicate device Stimulator have the same intended use and fundamental technology. A side-by-side comparison of the TENS Series Electro-Stimulator and the cited predicate devices is included in the 510(k) submission. The TENS Series Electro-Stimulator is substantially equivalent to the technological features as the predicate devices.

| | | New device | Predicate device |
|----|---------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------|
| 1 | 510K# | K | K100117 |
| 2 | Device Name | TENS 2800 Stimulator<br>TENS 3000 Stimulator | LT3001 TENS Stimulator |
| 3 | Manufacturer | Koalaty Products., INC | Shenzhen Dongdixin<br>Technology Co., Ltd. |
| 4 | Power Source | 9V Battery | 9V Battery |
| | -Method of Line current isolation | Battery Supply N/A | Battery Supply N/A |
| | - Patient Leakage Current<br>-Normal condition<br>-Single fault condition | 1.2uA<br>1.3uA | 1.1uA<br>1.3uA |
| 5 | Number of Output Modes | 3 | 6 |
| 6 | Number of Output Channels | 2 | 2 |
| | Method of channel isolation | By enclosure | By enclosure |
| 7 | Regulated Current or regulated<br>Voltage? | Voltage control | Voltage control |
| 8 | Software/Firmware/<br>Microprocessor Control? | Yes | Yes |
| 9 | Automatic Overload Trip? | No | No |
| | Automatic Over Current Trip? | No | No |
| 10 | Automatic No Load Trip? | No | No |
| 11 | Automatic Shut off? | No | No |
| 12 | Patient Override Control? | No | No |
| 13 | Indicator Display | | |
| | -On/Off Status? | Yes | Yes |
| | -Voltage/Current Level? | Yes | Yes |
| | -Low Battery? | Yes | Yes |

Basic technological characteristics, new device vs. Predicate device

Section 05-Page 3 of 4

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Image /page/3/Picture/0 description: The image shows the logo for KoalaTY Products, INC. The logo features a stylized image of a koala's head on the left. To the right of the koala image, the text "KoalaTY Products, INC." is written in a bold, sans-serif font. Below the company name, the text "A Current Solutions Company" is written in a smaller, lighter font.

| 14 | Timer Range (minutes) | 15min, 30min, continue | 30min, 60min, continue |
|----|-------------------------------------|---------------------------------------------|--------------------------------------------|
| 15 | Waveform | Biphasic or Monophasic<br>Rectangular pulse | Biphasic Rectangular pulse |
| 16 | Pulse Width Range | 30-260us | 50-300us |
| 17 | Frequency | 2-150Hz | 2-120Hz |
| 18 | Compliance with Voluntary Standards | IEC60601-1, IEC60601-1-2,<br>IEC60601-2-10 | IEC60601-1, IEC60601-1-2,<br>IEC60601-2-10 |
| 19 | Compliance with 21 CFR 898? | Yes | Yes |
| 20 | Weight (grams.) | 115 grams(battery included) | 128 grams (battery included) |
| 21 | Dimensions (mm.) H x W x T | 95x65x23.5 | 102x64x26 |
| 22 | Housing Materials & Construction | Enclosure: ABS,94, V-1,80°C,UL Approved | Enclosure: ABS,94, V-1,80°C,UL<br>Approved |

### Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

TENS Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:

- IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety". >
- IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety -A Collateral Standard"
- IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of > nerve and muscle stimulators"

#### Conclusions: 8.

The TENS Series Stimulator, which includes models TENS 2800 and TENS 3000, has the same intended use and technological characteristics as the predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the TENS Series Electro-Stimulator is substantially equivalent to the predicate device.

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### 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 consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.

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

Koalaty Products, Inc. c/o Mr. Jeffrey D. Rongero Senior Project Engineer, UL Health Sciences Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, NC 27709

AUG 3 1 2010

Re: K102014

Trade/Device Name: TENS 2800, TENS 3000 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: August 11, 2010 Received: August 16, 2010

Dear Mr. Rongero:

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. Ilsting 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm].15809.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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KID2014

File No: WMI-04-TENS-FDA-04 Version: 1.1

## Indications for Use

AUG 31 2010

510(k) Number ( < 102014 ):

Device Name:

TENS 2800 Stimulator TENS 3000 Stimulator

## Indications for Use:

Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

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)

Raffi

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102014