REHASTIM 2, ERIGOPRO (FES)

K132416 · Hasomed GmbH · GZI · May 28, 2014 · Neurology

Device Facts

• Record ID: K132416
• Device Name: REHASTIM 2, ERIGOPRO (FES)
• Applicant: Hasomed GmbH
• Product Code: GZI · Neurology
• Decision Date: May 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ErigoPro is intended for medical purposes such as to increase to an upright or standing position in patients with circulatory, neurological, or musculoskeletal conditions. ErigoPro is also used for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy / redevelop muscles 3. Increasing local blood circulation 4. Maintaining or increasing joint range of motion The ErigoPro is for prescription use only.

Device Story

ErigoPro is an early rehabilitation robotic device combining a verticalization table with an integrated leg movement mechanism and synchronized Functional Electrical Stimulation (FES). The device provides cyclic leg loading to lower limbs during early verticalization. The RehaStim 2 controller generates electrical impulses across up to 8 channels to activate paralyzed muscles via surface electrodes. The system is PC-controlled; it synchronizes movement angles with stimulation parameters. Used in clinical settings for patient mobilization; healthcare providers manage therapy settings and session logs via a database interface. The device aims to facilitate early rehabilitation, improve circulation, and maintain muscle/joint function in patients with mobility impairments.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, technical comparison of output characteristics, and review of predicate device documentation. Safety and effectiveness of the verticalization and robotic leg movement components are supported by ongoing clinical use in the EU and USA.

Technological Characteristics

Powered muscle stimulator; 0-130mA charge-balanced rectangular impulses; 8-channel stimulation. Includes verticalization table and robotic leg movement mechanism. PC-controlled; Linux OS. Power: 110-240V, 800VA. Patient contact: Type BF. Connectivity: Database interface for therapy settings/logs. Sterilization: Not applicable (surface electrodes).

Indications for Use

Indicated for patients with circulatory, neurological, or musculoskeletal conditions requiring assistance to reach an upright or standing position, muscle spasm relaxation, prevention/retardation of disuse atrophy, increased local blood circulation, and maintenance/increase of joint range of motion. Prescription use only.

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

• RehaStim 2; RehaMove 2 (K112844)

Submission Summary (Full Text)

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K132416

MAY 2 8 2014

Special 510(k) RehaStim 2 / ErigoPro (FES)

# 009_510(k) summary

21CFR807.92 / special 510(k)

. . . . .

# Name of the legally marketed (unmodified) device

| Proprietary name: | RehaStim 2; |
|-------------------|-------------------------------------------------|
| | RehaMove 2 (RehaStim 2 with movement exerciser) |
| 510(k): | K112844 |
| Device Class: | class 2 device |
| Classification: | Neurology |

# Submitter's / owner's name, address, Telephone number, a contact person, and the date the summary was prepared:

.

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

Prepared on July 02, 2013

009_510(k) summary.docx - page 1 of 6

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

| Proprietary name: | RehaStim 2<br>ErigoPro (FES) |
|----------------------|------------------------------|
| Common Name: | Powered Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator |

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

| Manufacturer: | HASOMED GmbH |
|---------------|----------------------|
| Product: | RehaStim 2; RehaMove |
| K-number: | K112844 |
| Class: | class 2 device |
| Product Code: | GZI |

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

2

The Erigo is an early rehabilitation robotic device consisting of a verticalization table and an integrated leg movement mechanism. By moving the patient's legs, cyclic leg loading is applied to the lower limbs of the patient during early verticalization. The Erigo is controlled via a PC.

The ErigoBasic offers all basic functionalities to perform early and safe patient mobilization. With the ErigoPro, patient stimulation is additionally enhanced by the synchronized FES.

009_510(k) summary.docx - page 2 of 6

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The FES - stimulation controller RehaStim 2 generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. A connection cable enables the RehaStim 2 to receive the stimulation parameters from the ErigoPro control system. The electrode lead wires are used to connect ErigoPro-FES-Socket/RehaStim2 output and electrodes on skin. Every connected lead wire should connect to two electrodes (1 channel) for ErigoPro and 2x 4 channels for RehaStim2, respectively.

### Statement of the intended use of the device:

Both the RehaStim 2 and the ErigoPro (FES) 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

#### Technological Characteristics

The functions of the RehaMove 2 and RehaStim 2 are the same as the predicate device however there are certain technological similarities and differences as described below:

| Technology | RehaStim 2 /<br>ErigoPro (FES) | RehaStim 2 /<br>RehaMove 2 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | AC:<br><br>ErigoPro:<br><br>Total System: 110-240V<br>800VA<br><br>Includes RehaStim2 power<br>supply: cincon tr30m ac-<br>cording to EN60601-1 | AC and/or storage battery:<br><br>Power supply: cincon tr30m<br>according to EN60601-1<br><br>Battery: BMZ18650 V, Li-Ion<br>Mangan cells, 2S1P, C=<br>1600 mAh, |
| | | |
| | RehaStim2 (only):<br>AC: power supply: cincon<br>tr30m according to<br>EN60601-1<br><br>Battery: BMZ18650 V, Li-Ion<br>Mangan cells, 2S1P, C=<br>1600 mAh, | |
| Controller | Uses custom processor,<br>running LinuxOS ,running<br>custom software<br><br>ErigoPro: RehaStim2 is<br>controlled by ErigoPro<br>Control Panel | Uses custom processor,<br>running LinuxOS , running<br>custom software |
| Stimulator (energy<br>delivered) | 0-130mA charge balanced<br>stimulator with rectangular<br>impulses | 0-130mA charge balanced<br>stimulator with rectangular<br>impulses |
| patient part | Type: BF | Type: BF |
| movement exerciser | The Erigo is an early<br>rehabilitation robotic device<br>consisting of a<br>verticalization table and an<br>integrated leg movement<br>mechanism. | RehaMove 2: Uses motor to<br>create flywheel effect with<br>reduced weight and space |
| Passive cycling | ErigoPro: By moving the<br>patient's legs, cyclic leg<br>loading is applied to the<br>lower limbs of the patient<br>during early verticalization. | RehaMove 2: Utilizes motor<br>to provide assistance during<br>passive cycling |
| FES control | Synchronization of<br>movement angle and<br>stimulation control | Synchronization of<br>movement angle and<br>stimulation control |
| Database interface | Utilizes database interface<br>for storage and retrieval of<br>patient therapy settings and<br>storage of session logs | Utilizes database interface<br>for storage and retrieval of<br>patient therapy settings and<br>storage of session logs |

009_510(k) summary.docx - page 3 of 6

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009_510(k) summary.docx - page 4 of 6

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Table 1 Technological similarities and differences

#### 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 ErigoPro (FES). |
| 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 ErigoPro (FES) / RehaStim 2 device<br>was tested and technically compared with<br>the predicate device. |
| Control of system testing | The system testing was aligned to verify<br>performance to specification. |

#### Table 2 Performance data

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

#### HASOMED concludes that:

Both the ErigoPro (FES) and RehaStim 2 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 gradual verticalization, robotic leg movement, and cyclic leg loading has been extensively demonstrated in particular by the ongoing clinical use of the device 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 2 and ErigoPro (FES) and many clinical applications.

In conclusion, HASOMED's clinical and non- clinical testing have demonstrated that the RehaStim 2 and ErigoPro (FES) are as safe and effective as the predicate device.

009_510(k) summary.docx - page 5 of 6

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Product code:

GZI

Common Name:

Powered Muscle Stimulator

ﻧﻤﺎ

009__510(k) summary.docx - page 6 of 6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized human figure embracing the world, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white and is positioned on a white background.

#### Public Health Service

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

May 28, 2014

HASOMED GmbH Matthias Weber Managing Director Paui-Ecke-Strasse 1 39114 Magdeburg Germany

Re: K132416

> Trade Name: ErigoPro Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI, BXB, INQ Dated: April 15, 2014 Received: April 21, 2014

Dear Mr. Weber:

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 or any 1 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, piease 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/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

# Felipe Aguel -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K132416

#### Device Name ErigoPro

Indications for Use (Describe)

The ErigoPro is intended for medical purposes such as to increase to an upright or standing position in patients with circulatory, neurological, or musculoskeletal conditions.

ErigoPro is also used for:

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

The ErigoPro is for prescription use only.

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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Date: 2014.05.28 17:08:42 -04'00'

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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