(59 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard electrical stimulation technology.
Yes
The device is intended for therapeutic applications such as relaxation of muscle spasms, prevention of disease atrophy, increasing local blood circulation, muscle re-education, and maintaining or increasing range of motion. It also mentions equivalence to a predicate therapeutic device (TheraStim Muscle Stimulator).
No
Explanation: The "Intended Use / Indications for Use" section lists therapeutic applications such as relaxation of muscle spasms, prevention of disease atrophy, and increasing blood circulation, rather than tasks like diagnosis, screening, or monitoring.
No
The device description explicitly states it consists of a "table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes," which are hardware components. While control parameters are software-controlled, the core function relies on physical hardware.
Based on the provided information, the ARP Rx100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed (relaxation of muscle spasms, prevention of atrophy, increasing blood circulation, muscle re-education, maintaining range of motion) are all related to treating or affecting the human body directly. IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is described as an "electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes." This is consistent with a device that applies electrical stimulation to the body, not one that analyzes samples from the body.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
The ARP Rx100 is clearly a therapeutic device that applies electrical stimulation for physical rehabilitation purposes.
N/A
Intended Use / Indications for Use
The ARP Rx100 is intended for the following applications:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
Product codes
IPF
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
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
The ARP Rx100 has been demonstrated safe by testing to IEC 60601-2-10. The Device compared to the Predicate is substantially equivalent, safe and as effective.
Key Metrics
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
1093259
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| Submitted by: | ARP Manufacturing
7200 E. Dry Creek Road, Suite G-102
Centennial, CO 80112 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lewis Ward
L.W. Ward and Associates, Inc.
4655 Kirkwood Court
Boulder, CO 80301 |
| | DEC 1 7 2009 |
| Date Prepared: | September 3, 2009 |
| Product: | Trade Name: ARP Rx100
Common Name: Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered, 890.5850, Product Code IPF |
| Intended Use: | The ARP Rx100 is intended for the following applications:
Relaxation of muscle spasmsPrevention or retardation of disease atrophyIncreasing local blood circulationMuscle re-educationMaintaining or increasing range of motion |
| 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 Rx100 Powered Muscle Stimulator is substantially equivalent to the TheraStim Muscle Stimulator, K893851. The modes, frequency, output, and indications for use are substantially equivalent. |
| Test Data: | The ARP Rx100 has been demonstrated safe by testing to IEC 60601-2-10. The Device compared to the Predicate is substantially equivalent, safe and as effective. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ARP Manufacturing, Inc. % Regulatory Technology Services LLC Mr. Mark Job 1394 25th Street NW Buffalo, MN 55313
Re: K093259
Trade/Device Name: ARP Rx100 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator. Regulatory Class: Class II Product Code: IPF Dated: November 28, 2009 Received: December 2, 2009
Dear Mr. Job:
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 idications for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, Dr to 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.
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 devine (1 m he found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, PDA 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.
DEC 1 7 2009
2
Page 2- Mr. Mark Job
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ARP Rx100
Indications for Use:
The ARP Rx100 is indicated for the following applications:
- . Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation .
- Muscle re-education ●
- Maintaining or increasing range of motion .
AND/OR Prescription Use X (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)
FOR M. MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093259