REHASTIM & REHAMOVE

K073237 · Hasomed GmbH · GZI · Dec 27, 2007 · Neurology

Device Facts

• Record ID: K073237
• Device Name: REHASTIM & REHAMOVE
• Applicant: Hasomed GmbH
• Product Code: GZI · Neurology
• Decision Date: Dec 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Both the RehaStim and RehaMove are intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion

Device Story

RehaMove/RehaStim is a Functional Electrical Stimulation (FES) system for rehabilitation. Inputs: surface electrodes on paralyzed muscles; motor-driven cycle ergometer (MOTOMed viva II) or arm crank. Operation: RehaStim controller generates 8-channel charge-balanced rectangular electrical impulses to trigger muscle contractions; system operates in active mode (FES + motor) or passive mode (motor only). Used in clinics or home settings; operated by patients or clinicians. Output: muscle stimulation and motorized limb movement. Benefits: improved circulation, spasm reduction, atrophy prevention, and range of motion maintenance. Includes USB interface for PC connectivity and database for therapy settings/session logs. Allows users to remain in their own wheelchairs.

Clinical Evidence

Bench testing only. Performance verified through technical comparison of output characteristics, review of user documentation, and system testing against specifications. No clinical trial data provided; safety/effectiveness supported by established clinical use of the movement exerciser component and controller development history.

Technological Characteristics

Powered muscle stimulator; 8-channel charge-balanced stimulator (0-126mA, rectangular impulses); Type BF patient part. Components: motorized cycle ergometer/arm crank, FES controller, RS232/USB interfaces. Power: Mains/Battery. Connectivity: PC interface for database storage/retrieval. Software: Custom controller software.

Indications for Use

Indicated for general rehabilitation in patients with impaired functions of lower and upper extremities requiring muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, or maintenance/increase of range of motion.

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• RT300-S; RT300-SP (K060032)

Submission Summary (Full Text)

{0}------------------------------------------------

## K073237

# 5. 510(k) Summary

(1) Submitter's name, address, Telephone number, a contact person, and the data the summary was prepared:

Matthias Weber Hasomed GmbH Paul-Ecke-Strasse 1 39114 Magdeburg Germany Phone: [phone] Fax: [phone]

DEC 2 7 2007

Prepared on august 1th 2007

## (2) Name of device, including the trade or proprietary name if applicable, the common or usual name, and the classification name :

Proprietary name: RehaStim of HASOMED GmbH RehaMove (movement exerciser with arm crank, includes RehaStim) of HASOMED GmbH

Common Name: Powered Muscle Stimulator Classification Name: Powered Muscle Stimulator

## (3) Identification of the legally marketed device to which the submitter claims equivalence:

Manufacture: Restorative Therapies Inc. Product: "RT300-S"; "RT300-SP", K-number: K060032 Class: class 2 device Product Code: GZI

5-- 8 -

{1}------------------------------------------------

## (4) A description of the device that is the subject of the premarket notification submission:

The RehaMove is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of:

- (1) a motorized movement exerciser (MOTOTMed viva II) produced by Reckcompany
- (2) for alternative training of upper extremities a motorized arm crank with same characteristics can be used
- (3) FES stimulation controller RehaStim, that generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
- (4) an information cable (RS232) connects the RehaStim and the movement exerciser
- (5) 4 electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connected the RehaStim with the electrodes on the skin
- (6) an USB interface to connect the RehaStim to PC
- (7) The stand-alone mode of RehaStim allows training without movement exerciser.

The system RehaMove allows training for person with impaired functions of lower and upper extremities in two modes:

- (1) active mode, using FES support for muscle contractions and if necessary motor power of movement exerciser
- (2) passive mode only movement by motorized movement exerciser

#### (5) Statement of the intended use of the device:

Both the RehaStim and RehaMove are intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Maintaining or increasing range of motion

{2}------------------------------------------------

### (6) Technological Characteristics

The functions of the RehaMove and RehaStim are the same as the predicate device however there are certain technological similarities and differences as described below:

| Technology | RehaStim/RehaMove | RT300-S |
|-------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Power Source | Mains / Battery Power | Mains Power |
| Controller | Uses custom controller<br>running custom software | Based on Pocket PC<br>running custom software |
| Stimulator (energy delivered) | 0-126mA charge balanced stimulator with rectangular impulses | 0-140mA charge balanced stimulator with rectangular impulses |
| patient part | Type: BF | Type: BF |
| movement exerciser | RehaMove: Uses motor to create flywheel effect with reduced weight and space | Uses motor to create flywheel effect with reduced weight and space |
| Arm crank | Arm crank in the same possible like upper extremities | Arm crank in the same possible like upper extremities |
| Seating | Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer | Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer |
| Passive cycling | RehaMove: Utilizes motor to provide assistance during passive cycling | Utilizes motor to provide assistance during passive cycling |
| Database interface | Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs | Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs |

Table 6-1 Technological similarities and differences

{3}------------------------------------------------

### (7) Determination of substantial equivalence

| Test or procedure | Task |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Review of user documentation for<br>predicate device | It was reviewed that equivalent function-<br>nality was implemented in RehaMove. |
| Review of 510(K) submissions for<br>predicate device | Confirm technical specifications for<br>completion of predicate details in<br>comparison tables |
| Output characteristic measurement of new<br>device | The RehaMove / RehaStim device was<br>tested and technically compared with the<br>predicate device. |
| Control of system testing | The system testing was aligned to verify<br>performance to specification. |

Table 7-1 Performance data

It can be matched that there is a substantial equivalence in all important technical and medical characteristics to the to the premarket notification.

## HASOMED concludes that:

Both the RehaMove and RehaStim have the same intended use and the same output characteristics as the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness.

The safety and effectiveness of using a movement exerciser to simulate the predicate devices motor powered flywheel and provide passive cycling assistance has been extensively demonstrated in particular by the ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A.

The safety and effectiveness of the controller has been demonstrated over the development period of the RehaStim and RehaMove and many clinical applications.

The remote database enhances the safety and effectiveness of the system by ensuring that patients always starts a therapy session with their latest, accurate device settings.

In conclusion, HASOMED's clinical and non- clinical testing have demonstrated that the RehaStim and RehaMove are as safe and effective as the predicate device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 2007

Hasomed GmbH % Underwriters Laboratories, Inc. Mr. Casey Conry Senior Project Engineer 1285 Walt Whitman Road Melville, NY 11747

Re: K073237

Trade/Device Name: Rehastim & Rehamove Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: December 17, 2007 Received: December 20, 2007

Dear Mr. Conry:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{5}------------------------------------------------

Page 2 - Mr. Casey Conry

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

## 4. Indications for Use

510(k) Number (if known): --

Device Name:

RehaMove RehaStim (stand alone)

Indications for Use:

Both the RehaMove and RehaStim are intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Maintaining or increasing range of motion

Prescription Use *X*
(Part 21 CFR 801 Subpart D)

AND/OR

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)

*Farbara Breh*
(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number *K073237*

Page 1 of 1

4--7-