(130 days)
Not Found
No
The description focuses on synchronized electrical stimulation based on motion data from external exercise equipment, with configurable parameters. There is no mention of AI/ML algorithms for data analysis, pattern recognition, or adaptive stimulation.
Yes
The device is intended for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion, all of which are considered therapeutic applications.
No
The device is described as a stimulator used for rehabilitation purposes (muscle relaxation, preventing atrophy, increasing circulation, maintaining range of motion), not for diagnosing conditions.
No
The device description explicitly states it is an "8 channel External Functional Neuromuscular Stimulator" and mentions hardware components like "connection cable" and "Electrode lead wires". This indicates it is a physical device, not software-only.
Based on the provided information, the RehaStim 2 stimulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The RehaStim 2, as described, is an external device that applies electrical stimulation to muscles for therapeutic purposes. It does not analyze any bodily specimens.
- The intended use and device description clearly indicate its function is external electrical stimulation for rehabilitation. The listed indications for use (muscle spasms, disuse atrophy, blood circulation, range of motion) are all related to physical therapy and rehabilitation, not diagnostic testing of bodily fluids or tissues.
Therefore, the RehaStim 2 falls under the category of a therapeutic or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RehaStim 2 stimulator is intended for general rehabilitation
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- 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.
- Maintaining or increasing range of motion
Product codes (comma separated list FDA assigned to the subject device)
GZI
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.
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
should be used under the supervision of a clinician.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Review of user documentation for predicate device: It was reviewed that equivalent functionality was implemented.
- Review of 510(k) submissions for predicate device: Confirm technical specifications for completion of predicate details in comparison tables (see above)
- Output characteristic measurement of new device: The RehaStim 2 (2016) device was tested and technically compared with the predicate devices.
- Control of system testing: The system testing was aligned to verify performance to specification.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol of three stylized human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
l. SUBMITTER
| 510k Submitter: | Hasomed GmbH |
|---|---|
| Contact person: | Matthias Weber |
| Address: | Paul-Ecke-Strasse 1 |
| 39114 Magdeburg | |
| Germany | |
| Phone: | +493916230112 |
| Fax: | +493916230113 |
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:
4
| 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.
5
V. INDICATIONS FOR USE
The RehaStim 2 stimulator is 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
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
(2016) | RehaStim 2 /
ErigoPro (FES) | RehaStim 2 /
RehaMove 2 |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K132416 | K112844
primary predicate |
| Power Source | AC and/or storage
battery:
Power supply:
cincon tr30m ac-
cording to
EN60601-1
Battery:
BMZ18650 V, Li-
Ion Mangan cells,
2S1P, C= 1600
mAh, | AC:
ErigoPro:
Total System: 110-
230V 800VA
Includes
RehaStim2 power
supply: cincon
tr30m according to
EN60601-1 | AC and/or storage
battery:
Power supply:
cincon tr30m ac-
cording to
EN60601-1
Battery:
BMZ18650 V, Li-
Ion Mangan cells,
2S1P, C= 1600
mAh, |
| | | RehaStim2 (only):
AC: power supply:
cincon tr30m ac-
cording to
EN60601-1
Battery:
BMZ18650 V, Li-
Ion Mangan cells,
2S1P, C= 1600
mAh, | |
| Power input
(charging) | 9V, 3A, max. 30 W | RehaStim2: 9V,
3A, max. 30 W | 9V, 3A, max. 30 W |
| Operation time | ca. 90 min | ErigoPro: No
limitation by
battery
RehaStim2: ca. 90
min | ca. 90 min |
| Charging time | ca. 180 min | ErigoPro: N/A
RehaStim2: ca.
180 min | ca. 180 min |
| Controller | uses custom
controller
using embedded
Linux as basis
operating system,
running custom
software | uses custom
controller
using embedded
Linux as basis
operating system,
running custom
software
ErigoPro:
RehaStim2 is
controlled by | uses custom
controller
using embedded
Linux as basis
operating system,
running custom
software |
| | | ErigoPro Control
Panel | |
| Stimulator
(energy delivered) | 0-130mA charge
balanced
stimulator with
rectangular
impulses / same
hardware | 0-130mA charge
balanced
stimulator with
rectangular
impulses / same
hardware | 0-130mA charge
balanced
stimulator with
rectangular
impulses / same
hardware |
| Pulse width | max. 500 µs | max. 500 µs | max. 500 µs |
| Stimulation
frequency | max. 50 Hz | max. 50 Hz | max. 50 Hz |
| Number of
channels | 8 | 8 | 8 |
| Electrodes | HASOMED's
RehaTrodes only | HASOMED's
RehaTrodes only
ErigoPro:
HASOMED's
electrodes with
"distributed by
Hocoma" label | HASOMED's
RehaTrodes only |
| FES00200
RehaTrode | 2.0" x 3.5",
rectangle | 2.0" x 3.5",
rectangle | 2.0" x 3.5",
rectangle |
| FES00201
RehaTrode | 3.0" x 5.0",
rectangle | 3.0" x 5.0",
rectangle | 3.0" x 5.0",
rectangle |
| FES00202
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
combination with
different movement
exercisers for
walking and
cycling
applications | motor to robotic leg
movement and
cyclic leg loading
for early functional
mobilization | motor to create
flywheel effect with
reduced weight
and space |
| Communication
interface | FES 2 + FES 3;
FES 3-
bidirectional
communication,
controlling of
movement
exerciser
functionality
interface allows for
combination with
different devices | RehaStim2:
FES 2 + FES 3;
FES 3-
bidirectional
communication,
controlling of
movement
exerciser
functionality
ErigoPro: RS2-
ErigoMode -
bidirectional
communication,
controlling of FES,
synchronized with
the ErigoPro
device | FES 2 + FES 3;
FES 3-
bidirectional
communication,
controlling of
movement
exerciser
functionality |
| Control philosophy
of matching the
combined devices | Complete
stimulation control
implemented in
RehaStim 2,
movement
exerciser delivers
motion data for
synchronization of
stimulation and
movement | Parts of stimulation
control
implemented in
Erigo device | Complete
stimulation control
implemented in
RehaStim 2,
movement
exerciser delivers
motion data for
synchronization of
stimulation and
movement |
| Patient position | As usual in the
movement
exerciser device
combined with | Verticalization
table for early
rehabilitation | Allows user to
remain in their own
seating, e.g.
wheelchair
eliminating the
need for transfer |
| Passive cycling | Exercise
equipment: Utilizes
motor to provide
assistance during
passive walking or
cycling | ErigoPro (FES):
Utilizes motor for
robotic leg
movement and
cyclic leg loading | 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 | Utilizes database
interface for
storage and
retrieval of patient
therapy settings
and storage of
session logs |
6
7
8
9
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.
10
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 | |
| predicate device | It was reviewed that equivalent |
| functionality was implemented. | |
| Review of 510(k) submissions for | |
| predicate device | Confirm technical specifications for |
| completion of predicate details in | |
| comparison tables (see above) | |
| Output characteristic measurement of | |
| new device | The RehaStim 2 (2016) device was |
| tested and technically compared with | |
| the predicate devices. | |
| Control of system testing | The system testing was aligned to |
| 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
11
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.