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
1. Prevention or retardation of disuse atrophy / redevelop muscles
1. Increasing local blood circulation
1. Maintaining or increasing joint range of motion

The ErigoPro is for prescription use only.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RehaStim 2 / ErigoPro (FES) device based on the provided text:

Acceptance Criteria and Device Performance

The provided document (K132416) is a Special 510(k) submission for the RehaStim 2 / ErigoPro (FES). This type of submission generally relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with explicit acceptance criteria for performance metrics (like sensitivity, specificity, or AUC).

Instead, the acceptance criteria are implicitly defined by demonstrating that the modified device (RehaStim 2 / ErigoPro (FES)) has the same intended use and same output characteristics as the predicate device (RehaStim 2 / RehaMove 2), and that any technological differences do not raise new questions of safety and effectiveness.

Therefore, the "acceptance criteria" here are met by the successful demonstration of substantial equivalence through technical comparisons and non-clinical testing.

Table: Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criterion (Implied)	Reported Device Performance
Same Intended Use as Predicate Device	The RehaStim 2 and ErigoPro (FES) are intended for the same general rehabilitation uses (relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, maintaining/increasing range of motion) as the predicate. The ErigoPro also includes indications related to increasing to an upright/standing position.
Same Output Characteristics as Predicate Device	The Stimulator (energy delivered) for both the RehaStim 2 / ErigoPro (FES) and the predicate RehaStim 2 / RehaMove 2 is 0-130mA charge balanced stimulator with rectangular impulses. The document states that both the ErigoPro (FES) and RehaStim 2 have the "same output characteristics as the predicate device."
Technological Differences Do Not Raise New Safety/Effectiveness	The submission concluded that "The different technological characteristics do not raise new questions of safety and effectiveness." This was demonstrated through: - A review of user documentation for the predicate device to confirm equivalent functionality. - Review of 510(k) submissions for the predicate device to confirm technical specifications. - Output characteristic measurements of the new device. - Control of system testing to verify performance to specification.
Safety and Effectiveness of Components Demonstrated	The submission states: - "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."
Overall Substantial Equivalence to Predicate Device	HASOMED concludes that clinical and non-clinical testing demonstrated that the RehaStim 2 and ErigoPro (FES) are "as safe and effective as the predicate device."

Study Details Based on Provided Information:

The provided document describes a Special 510(k) submission, which typically focuses on demonstrating substantial equivalence of a modified device to a predicate device, rather than new clinical trials with primary endpoints and acceptance criteria in the traditional sense. The "study" here is primarily a comparative technical and performance assessment against a predicate device.

Sample size used for the test set and the data provenance:
- No specific "test set" with a defined sample size (e.g., number of patients or images) is mentioned in the context of a clinical study or data analysis in this document. The assessment is based on technical comparisons, existing clinical use of the predicate, and non-clinical testing.
- Data Provenance: The document refers to "ongoing clinical use of the device without the stimulation component both in the European Union and the U.S.A." indicating existing market data and experience from these regions. This would generally be considered retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this submission outlines a technical equivalence assessment rather than a diagnostic device evaluation requiring expert-derived ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for a technical equivalence submission.
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 MRMC or AI-assisted study was conducted or reported in this submission. The device is a "Powered Muscle Stimulator" and the submission is about its FES component, not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an AI algorithm. The performance assessment described is of the device's technical specifications and safety profile, not an algorithm's standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate device (RehaStim 2 / RehaMove 2) and the technical specifications and performance measurements of both the predicate and the modified device. For the "safety and effectiveness of using gradual verticalization, robotic leg movement, and cyclic leg loading," the "ground truth" is stated as having been "extensively demonstrated by the ongoing clinical use of the device without the stimulation component."
The sample size for the training set:
- Not applicable. This is not an AI or machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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:	+493916209190
Fax:	+493916230113

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 2ErigoPro (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:

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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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
1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. 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: 110-240V800VAIncludes RehaStim2 powersupply: cincon tr30m ac-cording to EN60601-1	AC and/or storage battery:Power supply: cincon tr30maccording to EN60601-1Battery: BMZ18650 V, Li-IonMangan cells, 2S1P, C=1600 mAh,

	RehaStim2 (only):AC: power supply: cincontr30m according toEN60601-1Battery: BMZ18650 V, Li-IonMangan cells, 2S1P, C=1600 mAh,
Controller	Uses custom processor,running LinuxOS ,runningcustom softwareErigoPro: RehaStim2 iscontrolled by ErigoProControl Panel	Uses custom processor,running LinuxOS , runningcustom software
Stimulator (energydelivered)	0-130mA charge balancedstimulator with rectangularimpulses	0-130mA charge balancedstimulator with rectangularimpulses
patient part	Type: BF	Type: BF
movement exerciser	The Erigo is an earlyrehabilitation robotic deviceconsisting of averticalization table and anintegrated leg movementmechanism.	RehaMove 2: Uses motor tocreate flywheel effect withreduced weight and space
Passive cycling	ErigoPro: By moving thepatient's legs, cyclic legloading is applied to thelower limbs of the patientduring early verticalization.	RehaMove 2: Utilizes motorto provide assistance duringpassive cycling
FES control	Synchronization ofmovement angle andstimulation control	Synchronization ofmovement angle andstimulation control
Database interface	Utilizes database interfacefor storage and retrieval ofpatient therapy settings andstorage of session logs	Utilizes database interfacefor storage and retrieval ofpatient therapy settings andstorage 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 forpredicate device	It was reviewed that equivalent function-nality was implemented in ErigoPro (FES).
Review of 510(K) submissions forpredicate device	Confirm technical specifications forcompletion of predicate details incomparison tables
Output characteristic measurement of newdevice	The ErigoPro (FES) / RehaStim 2 devicewas tested and technically compared withthe predicate device.
Control of system testing	The system testing was aligned to verifyperformance 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 (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

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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
1. Prevention or retardation of disuse atrophy / redevelop muscles
1. Increasing local blood circulation
1. 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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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).