XINIWAVE, MODEL XW-18

K100441 · International Trade Group, Inc. · NUH · Jul 15, 2010 · Neurology

Device Facts

• Record ID: K100441
• Device Name: XINIWAVE, MODEL XW-18
• Applicant: International Trade Group, Inc.
• Product Code: NUH · Neurology
• Decision Date: Jul 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

A. TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/ or normal non-commercial household work activities. B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

XINIXWAVE is a portable, battery-powered, dual-channel transcutaneous nerve stimulator (TENS) and neuromuscular stimulator (NMS). Device uses same internal circuitry for both modalities. User selects desired program and modality via device interface. Electrode pads are applied to the body, supported by a garment belt for lower back treatment. Device delivers electrical stimulation to muscles; intended for OTC use by patients for pain relief and muscle performance improvement. Healthcare provider involvement is not required for operation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable, battery-powered, dual-channel electrical stimulator. Housed in a lightweight cabinet. Uses same circuitry for both TENS and NMS modalities. Includes garment belt for electrode pad placement.

Indications for Use

Indicated for temporary relief of pain in sore/aching muscles of lower back, arms, and legs due to exercise or household strain; also indicated for stimulation of healthy muscles to improve/facilitate muscle performance. 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

• Endurance Therapeutics' T-1040 (K060846)

Submission Summary (Full Text)

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K100441

SECTION 5.0 ਟ I

International Trade Group, Incorporated 4663 Katie Lane Oxford, OH 45056 USA Tel: [phone]

JUL 1 5 2010

### 510(k) Summary

General Information 1.

Trade Name of Device:

Common/Usual Name:

## "XINIXWAVE"

Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator

Classification Group:

Classification Name:

Classification regulation:

Submitter's Name: Submitter's Address:

Manufacturer's Name: Manufacturer's Address:

Manufacturer's FDA Reg. No:

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NGX, NUH

Stimulator, Nerve, Transcutaneous or Pain Relief, Over-the-Counter Combined with Powered Muscle Stimulator, Overthe-Counter.

21CFR 882.5890 OTC & 890.5850 OTC

International Trade Group, Incorporated 4663 Katie Lane Oxford, OH 45056 USA

Mantra International (HK) Ltd. 1504 Vigor Industrial Bldg. Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China 3003741750

#### Device Description 2.

Device Description
The "XINIXWAVE" is a portable combined TENS and NMS dual channel device for OTC use. Housed in sturly but lightweight cabinet, the device is battery powered. The same circuitry is used to for both TENS and NMS.

#### Indications for Use 3.

Indications for Use
A. TENS: The device is intended to be used for the temporary relief of pain A. TENS: The doviee is intelleg muscles in the lower back, upper extremities associated with betwer extremities (legs) due to strain from exercise and/ or normal non-commercial household work activities.

B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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K10044)

#### 4. Substantial Equivalence

This product is substantially equivalent to the Endurance Therapeutics' T-1040 (K-060846). The device comes with a garment belt that is used to hold the electrode pads to treat the lower back muscles as does the predicate device. The device offers the user a choice of programs for both TENS and NMS as does the predicate device. The user can select either TENS or NMS modalities. In this way it is simply "two products in one" as is the cited predicate device.

#### 5. Performance Studies

Performance testing was conducted on the "XINIXWAVE" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device.

### 6. Conclusion

Based upon the Indications for use and performance studies the "XINIXWAVE" is shown to be substantially equivalent for its intended use.

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

International Trade Group, Inc. c/o Mr. Brent Reider President 4663 Katie Lane Oxford, Ohio 45056

JUL 1 5 2010

Re: K100441

Trade/Device Name: Xiniwave, Model XW-18 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NUH Dated: June 3, 2010 Received: June 17, 2010

Dear Mr. Reider:

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.

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Page 2 - Mr. Brent Reider

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 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/ucm115809.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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Lesia Alexander

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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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# Indications for Use

510(k) Number (if known):

K 100 44

Device Name: XINIWAVE (Combined TENS & NMS device)

Indications For Use:

A. TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/ or norrmal non-commercial household work activities.

B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use AND/OR Over-The-Counter Use X X (21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Daryl Kaufman

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

510(k) Number K100441

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