(28 days)
Not Found
No
The document describes a functional electrical stimulation (FES) system that uses a stimulator and a movement exerciser. It details the hardware components and modes of operation (active and passive) but makes no mention of AI or ML algorithms for controlling stimulation, adapting to patient response, or any other function. The control appears to be based on angle parameters and pre-defined stimulation patterns.
Yes
The device is intended for general rehabilitation and lists specific therapeutic indications such as relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, and maintaining/increasing range of motion.
No
The device is described as a Functional Electrical Stimulation (FES) system intended for rehabilitation, specifically for purposes like relaxation of muscle spasms, prevention of disuse atrophy, increasing blood circulation, and maintaining range of motion. None of these intended uses involve diagnosing a medical condition.
No
The device description explicitly details hardware components including a stimulator unit, movement exerciser, connection cables, electrode cables, and a battery, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for general rehabilitation, focusing on muscle function and range of motion. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device is a Functional Electrical Stimulation (FES) system that applies electrical impulses to muscles via surface electrodes. This is a physical intervention, not a diagnostic test performed on biological samples.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (like blood, urine, tissue) or providing diagnostic information about a disease or condition. The device's purpose is to stimulate muscles for therapeutic benefit.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Both the RehaMove 2 and RehaStim 2 are intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Maintaining or increasing range of motion
Product codes (comma separated list FDA assigned to the subject device)
GZI
Device Description
The RehaMove 2 is a portable Eunctional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: a motorized movement exerciser (MOTO Med viva II) produced by Reck-company and a stimulator unit (RehaStim 2) produced by Hasomed GmbH. For alternative training of upper extremities a motorized arm crank with same characteristics can be used. The stand-alone mode of RehaStim 2 allows training without movement exerciser.
The system RehaMove 2 allows training for person with impaired functions of lower and upper extremities in two modes:
active mode - using FES support for muscle contractions and if necessary motor power of movement exerciser
passive mode - only movement by motorized movement exerciser
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 to receive angle-parameters and to control the Reck Viva II movement exerciser. Two electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connect the RehaStim 2 with the electrodes on the skin. A USB interface gives the possibility to connect the RehaStim 2 to the PC e.g. connect to patient database.
The RehaStim 2 can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The RehaMove 2 / RehaStim 2 device was tested and technically compared with the predicate device.
The system testing was aligned to verify performance to specification.
HASOMED's clinical and non- clinical testing have demonstrated that the RehaStim 2 and RehaMove 2 are as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
OCT 2 7 2011
Special 510(k) RehaStim 2 / RehaMove 2
05 510(k) summary
21CFR807.92 / special 510(k)
Name of the legally marketed (unmodified) device
. "
| Proprietary name: | RehaStim; |
|---|---|
| RehaMove (RehaStim with movement exerciser) | |
| 510(k): | K073237 |
| 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:
39114 Magdeburg
+493916209190
Paul-Ecke-Strasse 1
Germany
Phone:
Fax: +493916230113
Prepared on September 26 2011
1
Name of device, including the trade or proprietary name if applicable, the common or usual name, and the classification name :
"RehaStim 2" of HASOMED GmbH Proprietary name:
"RehaMove 2" (movement exerciser with arm crank, includes RehaStim) of HASOMED GmbH
| Common Name: | Powered Muscle Stimulator |
|---|---|
| Classification Name: | Powered Muscle Stimulator |
ldentification of the legally marketed device to which the submitter claims equivalence:
| Manufacturer: | HASOMED GmbH |
|---|---|
| Product: | "RehaStim" ; "RehaMove" (Version 1) |
| K-number: | K073237 |
| Class: | class 2 device |
| Product Code: | GZI |
A description of the device that is the subject of the premarket notification submission:
The RehaMove 2 is a portable Eunctional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of: a motorized movement exerciser (MOTO Med viva II) produced by Reck-company and a stimulator unit (RehaStim 2) produced by Hasomed GmbH. For alternative training of upper extremities a motorized arm crank with same characteristics can be used. The stand-alone mode of RehaStim 2 allows training without movement exerciser.
2
The system RehaMove 2 allows training for person with impaired functions of lower and upper extremities in two modes:
active mode - using FES support for muscle contractions and if necessary motor power of movement exerciser
passive mode - only movement by motorized movement exerciser
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 to receive angle-parameters and to control the Reck Viva II movement exerciser. Two electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connect the RehaStim 2 with the electrodes on the skin. A USB interface gives the possibility to connect the RehaStim 2 to the PC e.g. connect to patient database.
The RehaStim 2 can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
Statement of the intended use of the device:
Both the RehaStim 2 and RehaMove 2 are intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation 3.
-
- Maintaining or increasing range of motion
3
Technological Characteristics
The functions of the RehaMove 2 and RehaStim 2 are the predicate device however there are certain technological similarities and differences as described below:
| Technology | RehaStim 2 /
RehaMove 2 | RehaStim/RehaMove |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Power Source | AC and/or storage battery:
Power supply: cincon tr30m
according to EN60601-1 | AC and/or storage battery:
Power supply :mascot typ9920
according to EN60601-1 |
| | Battery: BMZ18650 V, Li-Ion
Mangan cells, 2S1P, C= 1600
mAh, | Battery: SANYO, NiMh,
C= 2700 mAh |
| Controller | Uses custom processor,
running LinuxOS ,running
custom software | Uses custom controller
running custom software |
| Stimulator (energy delivered) | 0-130mA charge balanced
stimulator with rectangular
impulses | 0-130mA charge balanced
stimulator with rectangular
impulses |
| patient part | Type: BF | Type: BF |
| movement exerciser | RehaMove 2: Uses motor to
create flywheel effect with
reduced weight and space | RehaMove: Uses motor to
create flywheel effect with
reduced weight and space |
| Arm crank | Arm crank gives same upper
extremities training
possibilities as with lower
extremities | Arm crank gives same upper
extremities training
possibilities as with lower
extremities |
| | Uses motor to create flywheel
effect with reduced weight
and space | Uses motor to create flywheel
effect with reduced weight
and space |
| 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 2: Utilizes motor to
provide assistance during
passive cycling | RehaMove: 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 |
4
Table 5-1 Technological similarities and differences
Determination of substantial equivalence
| Test or procedure | Task |
|---|---|
| Review of user documentation for | |
| predicate device | It was reviewed that equivalent function- |
| nality was implemented in RehaMove 2. | |
| Review of 510(K) submissions for | |
| predicate device | Confirm technical specifications for |
| completion of predicate details in | |
| comparison tables | |
| Output characteristic measurement of new | |
| device | The RehaMove 2 / RehaStim 2 device was |
| tested and technically compared with the | |
| predicate device. | |
| Control of system testing | The system testing was aligned to verify |
| performance to specification. |
Table 5-2 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:
5
Both the RehaMove 2 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 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 2 and RehaMove 2 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 2 and RehaMove 2 are as safe and effective as the predicate device.
Product code:
Common Name:
Powered Muscle Stimulator
GZI
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 7 2011
Hasomed GMBH % Mr Matthias Weber HASOMED GmbH Paul-Ecke-Strasse 1 39114 Magdeburg Germany
Re: K112844
Trade/Device Name: RehaMove 2 & RehaStim 2 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: September 27, 2011 Received: September 29, 2011
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 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-
7
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Elinor R. Fehim
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
04 Indications for Use
K112844 510k number if known:
Device Name:
RehaMove 2
RehaStim 2 (stand alone)
Indications for Use:
Both the RehaMove 2 and RehaStim 2 are intended for general rehabilitation for:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Maintaining or increasing range of motion
Prescription Use _ V (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)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number K112844