RehaStim 2

K162683 · Hasomed GmbH · GZI · Feb 3, 2017 · Neurology

Device Facts

• Record ID: K162683
• Device Name: RehaStim 2
• Applicant: Hasomed GmbH
• Product Code: GZI · Neurology
• Decision Date: Feb 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RehaStim 2 stimulator is intended for general rehabilitation 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion The RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

Device Story

RehaStim 2 is an 8-channel external functional neuromuscular stimulator (FES). It functions as a stand-alone device or integrates with external motion trainers (cycling/walking) via a serial interface (USB/FTDI). The device receives motion data (gait cycle percentage) from the exerciser every 10ms; it uses this data to synchronize electrical stimulation pulses to specific muscle groups based on the movement phase. Stimulation parameters are configured within the stimulator. Operated under clinician supervision in clinical settings. Output consists of charge-balanced rectangular electrical impulses (0-130mA, max 500µs pulse width, max 50Hz frequency) delivered via skin electrodes. Benefits include muscle spasm reduction, atrophy prevention, improved circulation, and range of motion maintenance. The device uses a custom controller running embedded Linux.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, verification, and validation of hardware and software, and comparison of technical specifications against predicate devices.

Technological Characteristics

8-channel FES; 0-130mA output; max 50Hz; max 500µs pulse width; Type BF applied part. Power: AC (Cincon TR30M, EN60601-1) or Li-Ion battery (BMZ18650). Connectivity: Serial interface (USB/FTDI) for motion data. Controller: Embedded Linux. Electrodes: HASOMED RehaTrodes. Sterilization: Not specified.

Indications for Use

Indicated for general rehabilitation in patients requiring relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, or maintenance/increase of range of motion. Used under clinician supervision.

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

• RehaMove 2 (K112844)
• ErigoPro (FES) (K132416)

Submission Summary (Full Text)

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

February 3, 2017

HASOMED Gmbh Matthias Ueltzen Quality Management & Regulatory Affairs Paul-Ecke-Str. 1 Magdeburg, SA 39114 Germany

Re: K162683

Trade/Device Name: RehaStim 2 Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: December 22, 2016 Received: December 27, 2016

Dear Mr. Ueltzen:

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162683

Device Name RehaStim 2

Indications for Use (Describe) The RehaStim 2 stimulator is intended for general rehabilitation

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

The RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

#### l. SUBMITTER

| 510k Submitter: | Hasomed GmbH |
|-----------------|---------------------------------------------------|
| Contact person: | Matthias Weber |
| Address: | Paul-Ecke-Strasse 1<br>39114 Magdeburg<br>Germany |
| Phone: | [phone] |
| Fax: | [phone] |

Prepared 2016-09-22, revised 2016-11-22, 2017-01-20, 2017-01-26, and 2017-02-02.

#### II. DEVICE

## Modification to an existing device

| Proprietary name: | RehaStim 2 |
|----------------------|---------------------------|
| Common Name: | Powered Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator |
| Device Class: | class 2 device |
| Classification: | Neurology |
| Product code: | GZI |

#### III. PREDICATE DEVICE

## Device 1 – primary predicate

RehaStim 2; Proprietary name:

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| | RehaMove 2 (RehaStim 2 with movement exerciser) | |
|-----------------|-------------------------------------------------|--|
| 510(k): | K112844 | |
| Device Class: | class 2 device | |
| Classification: | Neurology | |
| Product code: | GZI | |
| Common Name: | Powered Muscle Stimulator | |

## Device 2

| Proprietary name: | RehaStim 2; |
|-------------------|---------------------------|
| | ErigoPro (FES) |
| 510(k): | K132416 |
| Device Class: | class 2 device |
| Classification: | Neurology |
| Product code: | GZI, BXB, INQ |
| Common Name: | Powered Muscle Stimulator |

#### IV. DEVICE DESCRIPTION

RehaStim 2 is a 8 channel External Functional Neuromuscular Stimulator. RehaStim 2 can be used as a stand-alone device or in combination with an external motion trainer for cycling or walking applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

A connection cable enables the RehaStim 2 to receive motion data from the external movement exerciser device for walking or cycling applications in order to apply electrical stimulation synchronized with the movement. The stimulation is performed according to the motion data. The stimulation parameters can be configured inside the stimulator.

Electrode lead wires are used to connect RehaStim2 output and electrodes on skin.

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#### V. INDICATIONS FOR USE

The RehaStim 2 stimulator is 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

The RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The functions of the RehaStim 2 (2016) are the same as the predicate devices ErigoPro (FES), RehaMove 2, and RehaStim 2 remained the same, however there are certain technological similarities and differences as described below:

| Technology | RehaStim 2<br>(2016) | RehaStim 2 /<br>ErigoPro (FES) | RehaStim 2 /<br>RehaMove 2 |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K132416 | K112844<br>primary predicate |
| Power Source | AC and/or storage<br>battery:<br>Power supply:<br>cincon tr30m ac-<br>cording to<br>EN60601-1<br>Battery:<br>BMZ18650 V, Li-<br>Ion Mangan cells,<br>2S1P, C= 1600<br>mAh, | AC:<br>ErigoPro:<br>Total System: 110-<br>230V 800VA<br>Includes<br>RehaStim2 power<br>supply: cincon<br>tr30m according to<br>EN60601-1 | AC and/or storage<br>battery:<br>Power supply:<br>cincon tr30m ac-<br>cording to<br>EN60601-1<br>Battery:<br>BMZ18650 V, Li-<br>Ion Mangan cells,<br>2S1P, C= 1600<br>mAh, |
| | | RehaStim2 (only):<br>AC: power supply:<br>cincon tr30m ac-<br>cording to<br>EN60601-1<br>Battery:<br>BMZ18650 V, Li-<br>Ion Mangan cells,<br>2S1P, C= 1600<br>mAh, | |
| Power input<br>(charging) | 9V, 3A, max. 30 W | RehaStim2: 9V,<br>3A, max. 30 W | 9V, 3A, max. 30 W |
| Operation time | ca. 90 min | ErigoPro: No<br>limitation by<br>battery<br>RehaStim2: ca. 90<br>min | ca. 90 min |
| Charging time | ca. 180 min | ErigoPro: N/A<br>RehaStim2: ca.<br>180 min | ca. 180 min |
| Controller | uses custom<br>controller<br>using embedded<br>Linux as basis<br>operating system,<br>running custom<br>software | uses custom<br>controller<br>using embedded<br>Linux as basis<br>operating system,<br>running custom<br>software<br>ErigoPro:<br>RehaStim2 is<br>controlled by | uses custom<br>controller<br>using embedded<br>Linux as basis<br>operating system,<br>running custom<br>software |
| | | ErigoPro Control<br>Panel | |
| Stimulator<br>(energy delivered) | 0-130mA charge<br>balanced<br>stimulator with<br>rectangular<br>impulses / same<br>hardware | 0-130mA charge<br>balanced<br>stimulator with<br>rectangular<br>impulses / same<br>hardware | 0-130mA charge<br>balanced<br>stimulator with<br>rectangular<br>impulses / same<br>hardware |
| Pulse width | max. 500 µs | max. 500 µs | max. 500 µs |
| Stimulation<br>frequency | max. 50 Hz | max. 50 Hz | max. 50 Hz |
| Number of<br>channels | 8 | 8 | 8 |
| Electrodes | HASOMED's<br>RehaTrodes only | HASOMED's<br>RehaTrodes only<br>ErigoPro:<br>HASOMED's<br>electrodes with<br>"distributed by<br>Hocoma" label | HASOMED's<br>RehaTrodes only |
| FES00200<br>RehaTrode | 2.0" x 3.5",<br>rectangle | 2.0" x 3.5",<br>rectangle | 2.0" x 3.5",<br>rectangle |
| FES00201<br>RehaTrode | 3.0" x 5.0",<br>rectangle | 3.0" x 5.0",<br>rectangle | 3.0" x 5.0",<br>rectangle |
| FES00202<br>RehaTrode | 1.5" x 2.5" oval | 1.5" x 2.5" oval | 1.5" x 2.5" oval |
| Applied part | Type BF | Type BF | Type BF |
| Movement | RehaStim 2 (2016) | ErigoPro: uses | RehaMove: Uses |
| exerciser | is intended for<br>combination with<br>different movement<br>exercisers for<br>walking and<br>cycling<br>applications | motor to robotic leg<br>movement and<br>cyclic leg loading<br>for early functional<br>mobilization | motor to create<br>flywheel effect with<br>reduced weight<br>and space |
| Communication<br>interface | FES 2 + FES 3;<br>FES 3-<br>bidirectional<br>communication,<br>controlling of<br>movement<br>exerciser<br>functionality<br>interface allows for<br>combination with<br>different devices | RehaStim2:<br>FES 2 + FES 3;<br>FES 3-<br>bidirectional<br>communication,<br>controlling of<br>movement<br>exerciser<br>functionality<br>ErigoPro: RS2-<br>ErigoMode -<br>bidirectional<br>communication,<br>controlling of FES,<br>synchronized with<br>the ErigoPro<br>device | FES 2 + FES 3;<br>FES 3-<br>bidirectional<br>communication,<br>controlling of<br>movement<br>exerciser<br>functionality |
| Control philosophy<br>of matching the<br>combined devices | Complete<br>stimulation control<br>implemented in<br>RehaStim 2,<br>movement<br>exerciser delivers<br>motion data for<br>synchronization of<br>stimulation and<br>movement | Parts of stimulation<br>control<br>implemented in<br>Erigo device | Complete<br>stimulation control<br>implemented in<br>RehaStim 2,<br>movement<br>exerciser delivers<br>motion data for<br>synchronization of<br>stimulation and<br>movement |
| Patient position | As usual in the<br>movement<br>exerciser device<br>combined with | Verticalization<br>table for early<br>rehabilitation | Allows user to<br>remain in their own<br>seating, e.g.<br>wheelchair<br>eliminating the<br>need for transfer |
| Passive cycling | Exercise<br>equipment: Utilizes<br>motor to provide<br>assistance during<br>passive walking or<br>cycling | ErigoPro (FES):<br>Utilizes motor for<br>robotic leg<br>movement and<br>cyclic leg loading | RehaMove:<br>Utilizes motor to<br>provide assistance<br>during passive<br>cycling |
| Database interface | Utilizes database<br>interface for<br>storage and<br>retrieval of patient<br>therapy settings<br>and storage of<br>session logs | Utilizes database<br>interface for<br>storage and<br>retrieval of patient<br>therapy settings<br>and storage of<br>session logs | Utilizes database<br>interface for<br>storage and<br>retrieval of patient<br>therapy settings<br>and storage of<br>session logs |

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#### Table 1 Technological similarities and differences

The difference is in the control philosophy of the device combinations: In RehaStim 2 / RehaMove 2 the complete stimulation know-how is in the controller of the stimulation device RehaStim 2. In ErigoPro (FES) some of the stimulation control is implemented in the Erigo control. In the new device, stimulation control is completely implemented in the stimulation device and an interface is used for input of motion data into the stimulator. The stimulation is performed according to the motion data. The motion data are delivered via a serial interface (USB, FTDI) as percentage of full gait cycle at a rate of about 10 ms from the exerciser to the stimulator. A proprietary protocol is used. Based on this gait information, stimulation is activated at pre-defined values to the muscles needed according to the actual phase of gait. A proprietary testing protocol conducted by Hasomed GmbH is being used for validation and verification of RehaStim 2 for use with an exercise equipment. Hasomed will conduct risk hazard analysis to determine if additional testing (e.g. electrical safety, EMC, verification and validation) is necessary to ensure safety and effectiveness when using the RehaStim 2 with an exercise equipment.

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#### VII. PERFORMANCE DATA

The RehaStim 2 (2016) and both predicate devices (ErigoPro (FES) and RehaStim 2 / RehaMove 2) have the same intended use and the same output characteristics. The different technological characteristics do not raise new questions of safety and effectiveness.

The safety and effectiveness of the single stimulator device RehaStim 2 is extensively demonstrated by using the device for many years.

The safety and effectiveness of combining the electrostimulation device RehaStim 2 with movement exercisers or with devices for early functional mobilization of bedridden patients have been extensively demonstrated by the ongoing use of the predicate devices RehaStim 2 / ErigoPro (FES) and RehaStim 2 / RehaMove 2, respectively.

The safety and effectiveness of the controller has been demonstrated over the development period of the RehaStim 2 (2016). For combining the device with exercise equipment for walking and cycling applications, clear assessment instructions for verification and validation ensure, that no new questions of safety and effectiveness can be introduced by the combination of the products.

| Test or procedure | Task |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Review of user documentation for<br>predicate device | It was reviewed that equivalent<br>functionality was implemented. |
| Review of 510(k) submissions for<br>predicate device | Confirm technical specifications for<br>completion of predicate details in<br>comparison tables (see above) |
| Output characteristic measurement of<br>new device | The RehaStim 2 (2016) device was<br>tested and technically compared with<br>the predicate devices. |
| Control of system testing | The system testing was aligned to<br>verify performance to specification. |

## Determination of substantial equivalence

#### Table 2 Performance data

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

VIII. CONCLUSIONS

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### 510(k) RehaStim 2 (2016)

Since the intended use of the predicate devices is the same and the therapeutic parameters did not change, no clinical testing was required. The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the device will perform as intended in the specified use conditions. Hasomed concludes that the device performs comparably to the predicate devices that are currently marketed for the same intended use.