(148 days)
K-060846
Not Found
No
The summary describes a standard TENS/NMS device with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is described as both a TENS (Transcutaneous Electrical Nerve Stimulator) and NMS (Neuromuscular Stimulator) device, with stated intended uses for pain relief and muscle performance improvement, which are therapeutic applications.
No
The device's intended uses are for temporary pain relief (TENS) and muscle stimulation for performance improvement (NMS), not for diagnosing conditions.
No
The device description explicitly states it is a "portable combined TENS and NMS dual channel device" housed in a "sturdy but lightweight cabinet" and is "battery powered," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief of pain and muscle stimulation. These are therapeutic applications, not diagnostic ones. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a portable TENS and NMS device, which are types of electrical stimulators applied externally to the body. This is consistent with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the "XINIXWAVE" device, as described, falls under the category of a therapeutic device, specifically an electrical stimulator, and not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NGX, NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back, upper extremities (arms) and lower extremities (legs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the "XINIXWAVE" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K-060846
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
SECTION 5.0 ਟ I
International Trade Group, Incorporated 4663 Katie Lane Oxford, OH 45056 USA Tel: 614-568-7000
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:
ర్లు
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a wavy line representing its tail feathers.
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.
3
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 (800) 638-2041 or (301) 796-7100 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
Image /page/3/Picture/7 description: The image shows a close-up of a document with some handwritten text and some printed text. The handwritten text appears to be the word "for" in cursive. The printed text includes the words "Malv", "Direc", "Divis", and "Office". The text is black and the background is white.
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
4
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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