The RehaMove is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of:
(1) a motorized movement exerciser (MOTOTMed viva II) produced by Reckcompany
(2) for alternative training of upper extremities a motorized arm crank with same characteristics can be used
(3) FES stimulation controller RehaStim, that generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
(4) an information cable (RS232) connects the RehaStim and the movement exerciser
(5) 4 electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connected the RehaStim with the electrodes on the skin
(6) an USB interface to connect the RehaStim to PC
(7) The stand-alone mode of RehaStim allows training without movement exerciser.
The system RehaMove allows training for person with impaired functions of lower and upper extremities in two modes:
(1) active mode, using FES support for muscle contractions and if necessary motor power of movement exerciser
(2) passive mode only movement by motorized movement exerciser

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Analysis of K073237 for RehaStim and RehaMove

Acceptance Criteria and Device Performance:

The provided document does not explicitly present a table of numerical acceptance criteria (e.g., target accuracy, precision, or other specific performance metrics) for the RehaStim and RehaMove devices. Instead, the "acceptance criteria" are implied through the concept of substantial equivalence to a predicate device, the "RT300-S"; "RT300-SP" (K060032).

The core of the study presented here is a comparison with a predicate device to demonstrate that the new device is "as safe and effective" as the legally marketed predicate. Therefore, the "reported device performance" is framed in terms of its technological characteristics and intended use being similar to the predicate, and that any differences do not raise new questions of safety or effectiveness.

Implied Acceptance Criteria and Reported Performance (based on substantial equivalence):

Acceptance Criteria (Implied)	Reported Device Performance (RehaStim/RehaMove)
1. Same Intended Use	Both RehaStim and RehaMove 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. (Explicitly stated to be the same as the predicate device's intended use).
2. Similar Technological Characteristics (no new safety/effectiveness questions)	Power Source: Mains / Battery Power (Predicate: Mains Power) - Difference, but deemed not to raise new questions. Controller: Uses custom controller running custom software (Predicate: Based on Pocket PC running custom software) - Difference, but deemed not to raise new questions. Stimulator (energy delivered): 0-126mA charge balanced stimulator with rectangular impulses (Predicate: 0-140mA charge balanced stimulator with rectangular impulses) - Similar range, deemed not to raise new questions. Patient Part Type: BF (Predicate: BF) - Same. Movement Exerciser: Uses motor to create flywheel effect with reduced weight and space (Predicate: Uses motor to create flywheel effect with reduced weight and space) - Same concept. Arm Crank: Arm crank in the same possible like upper extremities (Predicate: Arm crank in the same possible like upper extremities) - Same concept. Seating: Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer (Predicate: Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer) - Same. Passive Cycling: Utilizes motor to provide assistance during passive cycling (Predicate: Utilizes motor to provide assistance during passive cycling) - Same. Database Interface: Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs (Predicate: Utilizes database interface for storage and retrieval of patient therapy settings and storage of session logs) - Same.
3. Equivalent Output Characteristics	The submission states: "Both the RehaMove and RehaStim have the same intended use and the same output characteristics as the predicate device." Output characteristic measurement of the new device was conducted and technically compared with the predicate device.
4. Safety and Effectiveness Equivalent	- The safety and effectiveness of using the movement exerciser has been demonstrated by ongoing clinical use (without stimulation component) in the EU and USA.- The safety and effectiveness of the controller has been demonstrated over its development and many clinical applications.- The remote database enhances safety and effectiveness by ensuring correct therapy settings. - HASOMED's clinical and non-clinical testing have demonstrated that the RehaStim and RehaMove are as safe and effective as the predicate device.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a separate "test set" in the context of a clinical trial with a defined number of subjects. The performance data primarily relies on a technical comparison with the predicate device and ongoing clinical use of components (the movement exerciser without FES).
- Data provenance: The document mentions "ongoing clinical use of the movement exerciser without the stimulation component both in the European Union and the U.S.A." This suggests historical data or real-world evidence from these regions. The "development period of the RehaStim and RehaMove and many clinical applications" for the controller also points to potentially internally generated data or general experience rather than a formal, distinct "test set" for this specific 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The submission focuses on technical specifications, equivalence to a predicate, and pre-existing evidence of component safety/effectiveness, rather than a de novo clinical study requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided, as the study described is not a clinical trial or image review requiring an adjudication process for a test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not conducted and is not applicable. This device is a functional electrical stimulator and movement exerciser, not an AI-powered diagnostic tool that human readers would interpret.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone" in this context is ambiguous. If it refers to the performance of the RehaStim stimulator without the movement exerciser, the document states: "The stand-alone mode of RehaStim allows training without movement exerciser." This implies that its functionality as a stimulator was considered independently.
- However, if "standalone" refers to an algorithm's performance without human interaction, that is not applicable as this is a medical device for therapeutic use, not an AI algorithm for interpretation or decision support.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is heavily based on demonstrating equivalence to the predicate device and leveraging the established safety and effectiveness of the predicate and component technologies (e.g., the movement exerciser component's prior clinical use, and the controller's development history).
- There is no mention of explicit "ground truth" derived from expert consensus, pathology, or specific outcomes data collected for a novel clinical trial in this submission to establish the device's efficacy against a gold standard. Instead, the argument is that its performance and safety are comparable to a device already deemed safe and effective.
The sample size for the training set:
- This information is not provided and is not applicable to the type of submission described. This is not an AI/machine learning device that involves a "training set." The development process mentioned for the controller ("development period of the RehaStim and RehaMove and many clinical applications") might imply iterative testing and refinement, but not a formal "training set" in the AI sense.
How the ground truth for the training set was established:
- This information is not provided and is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device.

Summary

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K073237

5. 510(k) Summary

(1) Submitter's name, address, Telephone number, a contact person, and the data the summary was prepared:

Matthias Weber Hasomed GmbH Paul-Ecke-Strasse 1 39114 Magdeburg Germany Phone: +493916107653 Fax: +493916230113

DEC 2 7 2007

Prepared on august 1th 2007

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

Proprietary name: RehaStim of HASOMED GmbH RehaMove (movement exerciser with arm crank, includes RehaStim) of HASOMED GmbH

Common Name: Powered Muscle Stimulator Classification Name: Powered Muscle Stimulator

(3) Identification of the legally marketed device to which the submitter claims equivalence:

Manufacture: Restorative Therapies Inc. Product: "RT300-S"; "RT300-SP", K-number: K060032 Class: class 2 device Product Code: GZI

5-- 8 -

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(4) A description of the device that is the subject of the premarket notification submission:

The RehaMove is a portable Functional Electrical Stimulation (FES) system based on a cycle ergometer and a stimulator. It consists of:

(1) a motorized movement exerciser (MOTOTMed viva II) produced by Reckcompany
(2) for alternative training of upper extremities a motorized arm crank with same characteristics can be used
(3) FES stimulation controller RehaStim, that generates impulses, on up to 8 channels simultaneously, to activate paralyzed muscles via surface electrodes. The RehaStim can be used as a portable (contains a battery) or stationary device for training and rehabilitation applications.
(4) an information cable (RS232) connects the RehaStim and the movement exerciser
(5) 4 electrode cables (at maximum 16 cutaneous electrodes for 8 channels) connected the RehaStim with the electrodes on the skin
(6) an USB interface to connect the RehaStim to PC
(7) The stand-alone mode of RehaStim allows training without movement exerciser.

The system RehaMove allows training for person with impaired functions of lower and upper extremities in two modes:

(1) active mode, using FES support for muscle contractions and if necessary motor power of movement exerciser
(2) passive mode only movement by motorized movement exerciser

(5) Statement of the intended use of the device:

Both the RehaStim and RehaMove are intended for general rehabilitation for:

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

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(6) Technological Characteristics

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

Technology	RehaStim/RehaMove	RT300-S
Power Source	Mains / Battery Power	Mains Power
Controller	Uses custom controllerrunning custom software	Based on Pocket PCrunning custom software
Stimulator (energy delivered)	0-126mA charge balanced stimulator with rectangular impulses	0-140mA charge balanced stimulator with rectangular impulses
patient part	Type: BF	Type: BF
movement exerciser	RehaMove: Uses motor to create flywheel effect with reduced weight and space	Uses motor to create flywheel effect with reduced weight and space
Arm crank	Arm crank in the same possible like upper extremities	Arm crank in the same possible like upper extremities
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: Utilizes motor to provide assistance during passive cycling	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

Table 6-1 Technological similarities and differences

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(7) Determination of substantial equivalence

Test or procedure	Task
Review of user documentation forpredicate device	It was reviewed that equivalent function-nality was implemented in RehaMove.
Review of 510(K) submissions forpredicate device	Confirm technical specifications forcompletion of predicate details incomparison tables
Output characteristic measurement of newdevice	The RehaMove / RehaStim device wastested and technically compared with thepredicate device.
Control of system testing	The system testing was aligned to verifyperformance to specification.

Table 7-1 Performance data

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

HASOMED concludes that:

Both the RehaMove and RehaStim 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 and RehaMove 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 and RehaMove are as safe and effective as the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 27 2007

Hasomed GmbH % Underwriters Laboratories, Inc. Mr. Casey Conry Senior Project Engineer 1285 Walt Whitman Road Melville, NY 11747

Re: K073237

Trade/Device Name: Rehastim & Rehamove Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: December 17, 2007 Received: December 20, 2007

Dear Mr. Conry:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Casey Conry

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

510(k) Number (if known): --

Device Name:

RehaMove RehaStim (stand alone)

Indications for Use:

Both the RehaMove and RehaStim are intended for general rehabilitation for:

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

Prescription Use X
(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)

Farbara Breh
(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number K073237

Page 1 of 1

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Regulation Number and Section

§ 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).