(360 days)
Not Found
No
The description details a simple neuromuscular stimulator with manual controls and no mention of AI/ML terms or capabilities.
No.
The intended use explicitly states, "The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions."
No
The device description and intended use state that it is for muscle conditioning by stimulating muscle performance, not for diagnosing medical diseases or conditions.
No
The device description explicitly states that the H-Wave Sport consists of a portable, battery-operated neuromuscular stimulator, lead wires, electrodes, and a battery charger, all of which are hardware components.
Based on the provided information, the H-Wave Sport is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance." This is an external application to the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description details a neuromuscular stimulator with electrodes and lead wires, which are applied externally.
- 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.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The H-Wave Sport's function is entirely external and focused on muscle performance, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The company performed laboratory bench testing to evaluate the H-Wave Sport device. In all instances, the H-Wave® Sport functioned as intended and the results observed were as expected. Performance data supports the use of low-frequency stimulation for endurance and active recovery.
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.
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
§ 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).
0
K08/998
JUL - 9 2009
510(k) Summary
Electronic Waveform Lab Inc.'s H-Wave® Sport
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Electronic Waveform Lab, Inc. 16168 Beach Boulevard Suite 232 Huntington Beach, CA 92647
Phone: (800) 874-9283 Facsimile: (714) 316-2833
Contact Person: Ryan P. Heaney, President
Date Prepared: February 3, 2009
Name of Device
H-Wave® Sport
Common or Usual Name/Classification Name
Powered muscle stimulator
Predicate Devices
H-Wave®, Electronic Waveform Lab, Inc. (K915230) Compex® Sport, Compex S.A. (K011880)
Intended Use / Indications for Use
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions ..
Technological Characteristics
The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.
1
Performance Data
The company performed laboratory bench testing to evaluate the H-Wave Sport device. In all instances, the H-Wave® Sport functioned as intended and the results observed were as expected. Performance data supports the use of low-frequency stimulation for endurance and active recovery.
Substantial Equivalence
The H-Wave® Sport is as safe and effective as the cleared H-Wave® and the cleared Compex® Sport. The H-Wave® Sport has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the H-Wave® Sport and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the H-Wave Sport is as safe and effective as the predicate devices. Thus, the H-Wave® Sport is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Electronic Waveform Lab, Inc. % Mr. Ryan P. Heaney, President 16168 Beach Boulevard Suite 232 Huntington Beach, California 92647
JUL - 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K081998
Trade/Device Name: H-Wave® Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: June 17, 2009 Received: June 17, 2009
Dear Mr. Heaney:
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 Amendmounts, 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 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.
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Page 2 - Mr. Ryan P. Heaney
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K081998
Device Name: H-Wave® Sport
Indications for Use:
The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KO81948
(Division Sign-Off) (Division Signical, Orthopedic, and Restorative Devices
510(k) Number
Page 1 of 1
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