BODYFLOW P2CH

K100862 · Physiomed Elektromedizin AG · IPF · Apr 21, 2011 · Physical Medicine

Device Facts

• Record ID: K100862
• Device Name: BODYFLOW P2CH
• Applicant: Physiomed Elektromedizin AG
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As prescribed by a physician for the following: - Increased local blood circulation - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Device Story

Bodyflow-P2CH is a powered muscle stimulator; delivers electrical current via skin-surface electrodes. Device features 2 output channels; supports 2 or 4 electrodes. Powered by internal rechargeable batteries. Operated under physician prescription; used to increase local blood circulation and prevent venous thrombosis via calf muscle stimulation. Output and waveform are adjustable based on treatment needs. Healthcare providers apply electrodes and set parameters to influence muscle activity, aiming to improve circulation and reduce post-surgical thrombosis risk.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1 (General Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators). No clinical data presented.

Technological Characteristics

Powered muscle stimulator; 2 output channels; rechargeable battery-powered. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 standards. Adjustable output and waveform programmability.

Indications for Use

Indicated for patients requiring increased local blood circulation or immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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

• LymphaVision (K003896)

Submission Summary (Full Text)

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# . Section 5: 510(k) Summary: K100862

The following information is provided as required by 21 CFR § 807.87 for the Bodyflow -P2CH 510(k) premarket notification for and in accordance with FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s", June 9, 1999.

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Bodyflow P2CH is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

| Applicant: | Physiomed Elektromedizin AG<br>Hutweide 10 |
|------------------------|------------------------------------------------------------------------|
| | D-91220 Schnaittach / Laipersdorf |
| | Phone: [phone] - 17 |
| | Facsimile: +49 9126 - 25 87-717 |
| | Registration Number: 3002892330 |
| Date of submission: | March 8, 2010 |
| Proprietary Name: | Bodyflow®-P2CH |
| Common Name: | Powered Muscle Stimulator |
| Classification Status: | 21 CFR 890.5850 |
| Product Code: | IPF |
| Panel: | Physical Medicine |
| Predicate Device: | Physiomed's LymphaVision, K003896, is substantially equivalent, for |
| | the purpose of this 510(k), to other devices that have received 510(k) |
| | clearance for similar indications for use. |

The Bodyflow®-P2CH is a device which delivers muscle stimulation by Device Description: applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by permanently installed, rechargeable batteries.

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Intended Use: As prescribed by a physician for the following:

- Increased local blood circulation
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Discussion of performance testing: Based on the output measurements, calculations, and safety testing/inspection; the Bodyflow -P2CH is safe with respect to electrical leakage current, electrode and lead wire safety, as well as output current and power density. Testing performed in accordance with the accepted FDA requirements of IEC 60601-1 Medical Electrical Equipment . Part 1: General Requirements for Safety, IEC 60601-1-2, Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility-Requirements and Test and IEC 60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators, found the Bodyflow -P2CH passed all of the applicable test.

#### Technological Characteristics and Substantial Equivalence

Output specifications, device design, waveforms and programmability demonstrated the Bodyflow® -P2CH to be substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Birgit Schmid Physiomed Elektromedizin AG Hutweide 10 D-91220 Schnaittach / Laipersdorf Germany

APR 2 1 2011

Re: K100862

Trade/Device Name: Bodyflow-P2CH Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: IPF Dated: April 12, 2011 Received: April 14, 2011

Dear Ms. Schmid:

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 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 – Birgit Schmid

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/MedicalDeyices/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

A.S. B- Drik

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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# Section 4: Indications for Use Statement

### Indications for Use

510(k) Number: K100862

Device Name: Bodyflow®-P2CH

Indications For Use: The Bodyflow -P2CH is a powered muscle stimulator intended for

- Increased local blood circulation
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(DWi (Dyvision Sign of Surgical, Orthopedic, Divisionative Devices

510(k) Number K100862

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