(138 days)
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Not Found
No
The document describes a standard electrical stimulator with different modes (IFC, NMES, TENS) and does not mention any AI or ML capabilities.
Yes
The device is described as a stimulator with modes for pain relief, muscle re-education, and increasing range of motion, which are all therapeutic applications.
No
The document describes the device's therapeutic uses (pain relief, muscle re-education, etc.), but it does not mention any diagnostic functions such as identifying diseases, conditions, or their causes.
No
The device description explicitly states "Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave," indicating it is a hardware device that performs electrical stimulation, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (pain relief, muscle re-education, etc.) are all related to treating or managing conditions within the body using electrical stimulation. IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose diseases or conditions.
- Device Description: The device is described as an electrical stimulator. This aligns with therapeutic devices, not diagnostic ones that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device falls under the category of therapeutic electrical stimulators, which are used to apply electrical currents to the body for various medical purposes.
N/A
Intended Use / Indications for Use
Interferential Mode (IFC)
- . Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
Neuromuscular Electrical Stimulation Mode (NMES)
- . Muscle Re-education
- . Prevention or Retardation of Disuse Atrophy
- . Increasing Local Blood Circulation
- . Maintaining or Increasing Range of Motion
- . Relaxation of Muscle Spasms
Transcutaneous Electrical Nerve Stimulation Mode (TENS)
- . Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.
Product codes
IPF, GZJ, LIH
Device Description
Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model Nex Wave
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows a logo with a stylized bird in flight, composed of three curved lines, suggesting movement and freedom. The bird is encircled by text, which appears to be part of the organization's name or mission statement. The logo is simple, using only black and white, which gives it a clean and professional look.
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20903-0002
Zynex Medical Incorporated % Mr. Jim Arnold 9990 Park Meadows Drive Lone Tree, Colorado 80124
SEP 2 0 2011
Re: K111279
Trade/Device Name: Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model Nex Wave Regulation Number: 21 CFR 890.5850 Regulation Name: Powered musele stimulator Regulatory Class: Class II Product Code: IPF. GZJ. LIH Dated: August 11. 2011 Received: August 12, 2011
Dear Mr. Arnold:
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.
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
1
Page 2 - Mr. Jim Arnold
device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality svstems (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.html 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.lda.gov/MedicalDevices/Safety/ReportalProblem/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/Medical.Devices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
cerely yours,
for Peter Thomson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Zynex Medical. The logo features the word "ZYNEX" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size below it. A curved line arches over the word "ZYNEX", adding a dynamic element to the design.
Zvnex Medical 9990 Park Meadows Dr Lone Tree, CO 80124. Main Office: 800-495-6670 Main Fax: 800-495-6695 www.zynexmed.com
INDICATIONS FOR USE
510(k) Number:
Device Name: Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.
Indications for Use:
Interferential Mode (IFC)
- . Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
Neuromuscular Electrical Stimulation Mode (NMES)
- . Muscle Re-education
- . Prevention or Retardation of Disuse Atrophy
- . Increasing Local Blood Circulation
- . Maintaining or Increasing Range of Motion
- . Relaxation of Muscle Spasms
Transcutaneous Electrical Nerve Stimulation Mode (TENS)
- . Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.
Prescription Use M (Part 21 CFR 801 Subpart D)
ﺮ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 4-1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111279