ARP RX100

K093259 · Arp Manufacturing, Inc. · IPF · Dec 17, 2009 · Physical Medicine

Device Facts

• Record ID: K093259
• Device Name: ARP RX100
• Applicant: Arp Manufacturing, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The ARP Rx100 is intended for the following applications: Relaxation of muscle spasms Prevention or retardation of disease atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion

Device Story

ARP Rx100 is a powered muscle stimulator; table-top electrical generator; produces continuous or interrupted electrical impulses; delivered via patient electrodes. Device parameters are software-controlled via LCD touch screen. Used in clinical settings to treat muscle spasms, atrophy, and circulation issues; aids in muscle re-education and range of motion maintenance. Healthcare providers operate the device to deliver therapeutic stimulation; output affects muscle activity and local blood flow; provides non-invasive therapeutic benefit to patients.

Clinical Evidence

Bench testing only. Safety demonstrated via testing to IEC 60601-2-10 standard.

Technological Characteristics

Table-top electrical generator; produces continuous or interrupted electrical impulses; patient electrodes; LCD touch screen interface; software-controlled parameters; Class II device (21 CFR 890.5850).

Indications for Use

Indicated for patients requiring relaxation of muscle spasms, prevention or retardation of disuse atrophy, increased local blood circulation, muscle re-education, and maintenance or increase of range of motion.

Regulatory Classification

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.

Predicate Devices

• TheraStim Muscle Stimulator (K893851)

Submission Summary (Full Text)

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## 1093259

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| Submitted by: | ARP Manufacturing<br>7200 E. Dry Creek Road, Suite G-102<br>Centennial, CO 80112 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lewis Ward<br>L.W. Ward and Associates, Inc.<br>4655 Kirkwood Court<br>Boulder, CO 80301 |
| | DEC 1 7 2009 |
| Date Prepared: | September 3, 2009 |
| Product: | Trade Name: ARP Rx100<br>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:<br><ul><li>Relaxation of muscle spasms</li><li>Prevention or retardation of disease atrophy</li><li>Increasing local blood circulation</li><li>Muscle re-education</li><li>Maintaining or increasing range of motion</li></ul> |
| 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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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

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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 [phone] or [phone] 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

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## 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