(299 days)
Not Found
No
The description focuses on robotic verticalization, leg movement, and functional electrical stimulation (FES) controlled by a PC. There is no mention of AI or ML algorithms for control, data analysis, or personalized therapy.
Yes
The device is described as having medical purposes, including the relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, and maintaining/increasing joint range of motion, which are therapeutic applications. It also incorporates Functional Electrical Stimulation (FES), a common therapeutic modality.
No
The ErigoPro is described as a rehabilitation device designed to assist with verticalization, leg movement, and muscle stimulation. Its stated intended uses relate to therapeutic benefits (e.g., relaxation of muscle spasms, increasing blood circulation, maintaining joint range of motion), not the identification or assessment of a medical condition.
No
The device description clearly states it consists of a verticalization table, an integrated leg movement mechanism, and a stimulation controller (RehaStim 2) which are all hardware components. While it is controlled via a PC, the device itself is not solely software.
Based on the provided information, the ErigoPro is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- ErigoPro's Function: The ErigoPro is a robotic device used for physical rehabilitation. It helps patients with circulatory, neurological, or musculoskeletal conditions to stand and move their legs. It also incorporates Functional Electrical Stimulation (FES) to activate muscles.
- Intended Use: The intended use clearly describes a physical therapy and rehabilitation function, not the analysis of biological specimens.
- Device Description: The description details a mechanical and electrical device that interacts directly with the patient's body, not with samples taken from the body.
Therefore, the ErigoPro falls under the category of a therapeutic or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Both the RehaStim 2 and the ErigoPro (FES) 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
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:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy / redevelop muscles
-
- Increasing local blood circulation
-
- Maintaining or increasing joint range of motion
The ErigoPro is for prescription use only.
Product codes
GZI, BXB, INQ
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
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
Not Found
Summary of Performance Studies
The ErigoPro (FES) / RehaStim 2 device was tested and technically compared with the predicate device. The system testing was aligned to verify performance to specification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: | +493916209190 |
| Fax: | +493916230113 |
Prepared on July 02, 2013
009_510(k) summary.docx - page 1 of 6
1
Name of device, including the trade or proprietary name if applicable, the common or usual name, and the classification name :
| Proprietary name: | RehaStim 2
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
2
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:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- 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 /
ErigoPro (FES) | RehaStim 2 /
RehaMove 2 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source | AC:
ErigoPro:
Total System: 110-240V
800VA
Includes RehaStim2 power
supply: cincon tr30m ac-
cording to EN60601-1 | AC and/or storage battery:
Power supply: cincon tr30m
according to EN60601-1
Battery: BMZ18650 V, Li-Ion
Mangan cells, 2S1P, C=
1600 mAh, |
| | | |
| | RehaStim2 (only):
AC: power supply: cincon
tr30m according to
EN60601-1
Battery: BMZ18650 V, Li-Ion
Mangan cells, 2S1P, C=
1600 mAh, | |
| Controller | Uses custom processor,
running LinuxOS ,running
custom software
ErigoPro: RehaStim2 is
controlled by ErigoPro
Control Panel | Uses custom processor,
running LinuxOS , 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 | The Erigo is an early
rehabilitation robotic device
consisting of a
verticalization table and an
integrated leg movement
mechanism. | RehaMove 2: Uses motor to
create flywheel effect with
reduced weight and space |
| Passive cycling | ErigoPro: By moving the
patient's legs, cyclic leg
loading is applied to the
lower limbs of the patient
during early verticalization. | RehaMove 2: Utilizes motor
to provide assistance during
passive cycling |
| FES control | Synchronization of
movement angle and
stimulation control | Synchronization of
movement angle and
stimulation control |
| 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 |
009_510(k) summary.docx - page 3 of 6
3
:
.
009_510(k) summary.docx - page 4 of 6
:
・
. . . . . .
4
Table 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 ErigoPro (FES). | |
| 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 ErigoPro (FES) / 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 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
5
Product code:
GZI
Common Name:
Powered Muscle Stimulator
ﻧﻤﺎ
009__510(k) summary.docx - page 6 of 6
:
6
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
7
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
8
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:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy / redevelop muscles
-
- Increasing local blood circulation
-
- 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.
9
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