(225 days)
Not Found
No
The summary describes a muscle stimulator with software-controlled parameters, but there is no mention of AI, ML, or any learning or adaptive capabilities based on data.
No
The device is explicitly stated as "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and is considered a "technique of muscle training," indicating it's for performance improvement rather than therapeutic application.
No
The device is intended to stimulate healthy muscles to improve performance, described as a "technique of muscle training," and explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions." These statements indicate its purpose is therapeutic/training, not diagnostic.
No
The device description explicitly states the system consists of a "table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ARP POV Sport is described as an electrical generator that stimulates healthy muscles externally through electrodes. It is used for muscle training and improving muscle performance.
- Intended Use: The intended use explicitly states it's for stimulating healthy muscles to improve or facilitate muscle performance and is not for diagnosing or treating medical conditions.
- No Sample Analysis: The description does not mention any analysis of biological samples.
Therefore, the ARP POV Sport falls under the category of a physical therapy or muscle stimulation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ARP POV Sport is intended for the following:
The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The ARP POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.
The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance.
The ARP POV Sport is considered a technique of muscle training.
Product codes
NGX
Device Description
The system consists of a table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes. Control parameters are software controlled through an LCD touch screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles
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 ARP POV Sport has been demonstrated safe by testing to IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000. The device compared to the predicate is substantially equivalent, safe and as effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
، – – – –
: ··········································································································································································· i : : : : ·
| Submitted by: | ARP Manufacturing
7200 E. Dry Creek Road, Suite g-102
Centennial, CO 80112 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AUG 10 2010 |
| | 1K093999 |
| Contact Person | Lewis Ward
L.W. Ward and Associates, Inc.
4655 Kirkwood Court
Boulder, CO 80301 |
| Date Prepared: | 5-27-10 |
| Product: | Trade Name: ARP POV Sport
Common Name: Powered Muscle Stimulator, OTC |
| Classification Name: | Stimulator, Muscle, Powered, 890.5850, Product Code NGX |
| Intended Use: | The ARP POV Sport is intended for the following: |
| | The ARP POV Sport is intended to stimulate healthy muscles in order to
improve or facilitate muscle performance. |
| | The ARP POV Sport is not intended to be used in conjunction with
therapy or treatment of medical diseases or medical conditions of any
kind. The ARP POV Sport is not designed for use on injured or ailing
muscles and its use on such muscles is contraindicated. |
| | The POV Sport's electrical impulses allow triggering action potential on
motoneurones of motornerves (excitations). These excitations of
motoneurones are transmitted to the muscle fibers via the motor endplate
where they generate mechanical muscle fiber responses that correspond to
muscle work. Depending on the parameters of the electrical impulses
(pulse frequency, duration of contraction, duration of rest, total session
duration), different types of muscle work can be imposed on the
stimulated muscles. |
| | The various types of muscle work that the POV Sport can impose on the
stimulated muscles are able to improve or facilitate muscle performance. |
| | The ARP POV Sport is considered a technique of muscle training. |
.
1
| Technological
Characteristics: | The system consists of a table top electrical generator producing optimal
continuous or interrupted electrical impulses through patient electrodes.
Control parameters are software controlled through an LCD touch screen. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | The POV Sport Powered Muscle Stimulator is substantially equivalent to
the Compex Sport K011880, the TheraStim Muscle Stimulator K893851,
and Endurance Therapeutics Model T1040 K060846. The modes,
frequency, output, and indications for use are substantially equivalent. |
| Test Data: | The ARP POV Sport has been demonstrated safe by testing to IEC 60601-
2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-
4:2000. The device compared to the predicate is substantially equivalent,
safe and as effective. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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-like figure with three lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ARP Manufacturing, Inc. % L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Re: K093999
Trade/Device Name: ARP POV Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: August 4, 2010 Received: August 6, 2010
AUG 1 0 2010
Dear Mr. Ward:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Lewis Ward
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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
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
16093999
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ARP POV Sport
AUG10 2010
Indications for Use:
The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind: The ARP POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.
The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance.
The ARP POV Sport is considered a technique of muscle training.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
__, and I'm not sure how to handle the signature.
(Division Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093999