C-MAX+ (PLUS)

• K Number: K130864
• Device Name: C-MAX+ (PLUS)
• Manufacturer: AAT ALBER ANTRIEBSTECHNIK GMBH
• Date Cleared: 2014-02-06 ( 315 days)
• Product Code: ILK
• Regulation Number: 890.5150

Intended Use

Powered patient stairway chair lift; Intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway. The product c-max+ (plus) offers motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.

Device Description

With the c-max+ people can transport a patient safely and comfortably up- and downstairs. The maximum load is 300kg. The device is safe due to automatic brakes and a rigid frame. It is suitable for almost all kinds of stairs, winding stairs excluded. The climbing system requires low maintenance and care. On stairs as well as on level ground C-Max+ proves its versatility. Removable arm rests make easy transferring from one chair to another possible. Due to its compact dimensions and foldable foot rest, the C-Max+ is easy to manoeuvre even on very narrow stair cases. For small, compact apartments with narrow doorways, the C-Max+ represents the ideal solution. At the heart of the matter lies the patented climbing mechanism, which virtually climbs stairs all by itself. It also makes the C-Max+ particularly versatile and safe. Once the patient has seated and fastened the seat belt, the care attendant needs little physical power to handle the C-Max+. The C-Max+ is individually adjustable. Wheels make the transport on the floor easy. The battery-powered stair-climbing mechanism is usercontrolled with adjustable speed and climbing-direction. The attendant can also choose a single-step-mode alternatively to fluent climbing. A safety-brake ensures safe stops during the stair-climbing.

Predicate Devices

K103122

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrical components, user control, and standard safety features, with no mention of AI or ML terms or functionalities.

Therapeutic

Yes
The device is described as mitigating mobility impairment caused by injury or other disease, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.

Diagnostic

No

The device is a powered patient stairway chair lift designed to assist individuals with mobility impairments in moving up and down stairs. Its stated purpose is to mitigate mobility impairment by moving a person, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical, motorized stairway chair lift with a rigid frame, wheels, a climbing mechanism, and a battery-powered system, indicating it is a hardware device with integrated software for control.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "mitigate mobility impairment caused by injury or other disease by moving a person up and down a stairway." This is a physical function, not a diagnostic one.
• Device Description: The description focuses on the mechanical aspects of the device, such as the climbing mechanism, frame, wheels, and battery-powered motor. It describes how it physically transports a person.
• Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing any diagnostic information about a person's health condition.
• Performance Studies: The performance studies listed are related to the physical safety and functionality of the device (mechanical strength, electrical safety, flammability, etc.), not diagnostic accuracy.
• Predicate Device: The predicate device is also a "powered patient stairway chair lift," which is consistent with a mobility aid, not a diagnostic device.

In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powered patient stairway chair lift; Intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.

The product c-max+ (plus) offers motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.

Product codes

ILK

Device Description

With the c-max+ people can transport a patient safely and comfortably up- and downstairs. The maximum load is 300kg. The device is safe due to automatic brakes and a rigid frame. It is suitable for almost all kinds of stairs, winding stairs excluded. The climbing system requires low maintenance and care.

On stairs as well as on level ground C-Max+ proves its versatility. Removable arm rests make easy transferring from one chair to another possible. Due to its compact dimensions and foldable foot rest, the C-Max+ is easy to manoeuvre even on very narrow stair cases. For small, compact apartments with narrow doorways, the C-Max+ represents the ideal solution.

Scientific Concept: At the heart of the matter lies the patented climbing mechanism, which virtually climbs stairs all by itself. It also makes the C-Max+ particularly versatile and safe.

Function: Once the patient has seated and fastened the seat belt, the care attendant needs little physical power to handle the C-Max+. The C-Max+ is individually adjustable. Wheels make the transport on the floor easy. The battery-powered stair-climbing mechanism is usercontrolled with adjustable speed and climbing-direction. The attendant can also choose a single-step-mode alternatively to fluent climbing. A safety-brake ensures safe stops during the stair-climbing.

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

Not Found

Summary of Performance Studies

Non-clinical tests were performed to determine substantial equivalence. The tests were performed according to recognized standards for powered patient stairway chair lifts. These are the applicable standards:

• To demonstrate the device's general safety, we performed non-clinical tests according to EN 12182: Technical aids for disabled persons-general requirements and test methods.
• To demonstrate the device's safe function under different standardized climatic conditions, we performed non-clinical tests according to ISO 7176-9: Wheelchairs -Part 9: Climatic tests for electric wheelchairs.
• To demonstrate the device's electrical safety, we performed non-clinical tests according to ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods.
• To demonstrate the device's safety concerning flammability, we performed non-clinical tests according to ISO 7176-16: Wheelchairs - Part 16: Resistance to ignition of upholstered parts -- Requirements and test methods.
• To demonstrate the device's electromagnetic-compatibility, we performed non-clinical tests according to ISQ 7176-21: Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers.
• To demonstrate the device's mechanical and functional safety, we performed non-clinical tests according to ISO 7176-23: Wheelchairs - Part 23: Requirements and test methods for attendant-operated stair-climbing devices.
• To demonstrate the device's biocompatibility, we performed non-clinical tests according to ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

Conclusion: The subject device C-Max+ is as safe, as effective, and performs as well as the predicate device but with a higher max. load. The performed non-clinical tests demonstrate the safety of the subject device's performance, electricity, electromagnetic-compatibility, mechanical strength and durability, flammability and biological/toxicological aspects.

Key Metrics

Not Found

Predicate Device(s)

K103122

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5150 Powered patient transport.

(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.

Summary

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FFB - 6 2014

Image /page/0/Picture/1 description: The image shows a logo with the letters "AAT" in bold, white font. The letters are positioned at the bottom of a black square with a rounded corner at the top right. The background is white, providing a strong contrast to the black square and white letters.

K130864

510(k) SUMMARY

February 4, 2014

Office of Device Evaluation U.S. Food & Drug Administration

In accordance with Section 807.92 (c), is hereby made the 510(k)-summary for our device "c-max+ (plus)"P, that we plan to introduce into interstate commercial distribution.

Applicant / 510(k)-owner:	AAT Alber Antriebstechnik GmbH
	Ehestetter Weg 11
	D-72458 Albstadt-Ebingen
	Phone: Tel. [phone]
	Fax [phone]
	Email: [e-mail]

Organization Number: 239600

Contact Person: Mrs. Stefanie D. Bankston BEO MedConsulting Berlin GmbH 3001 Ferndale Dr. League City TX 77573 Phone: [phone] email: [e-mail]

Devices Name:

• Proprietary name: c-max+ (plus) a.
• Common Name: Powered patient stairway chair lift b.
• Classification Name: 21 CFR 890.5150 Powered patient transport C.
• Device Class: II ರ.
• Classification Panel: Physical Medicine e.
• f. Product Code: ILK

ldentification of the legally marketed device to which we claim equivalence:

The c-max+ (plus) is substantial equivalent in intended use, design and function to the c-max by AAT Alber Antriebstechnik GmbH (K103122).

Device Description:

With the c-max+ people can transport a patient safely and comfortably up- and downstairs. The maximum load is 300kg. The device is safe due to automatic brakes and a rigid frame. It is suitable for almost all kinds of stairs, winding stairs excluded. The climbing system requires low maintenance and care.

On stairs as well as on level ground C-Max+ proves its versatility. Removable arm rests make easy transferring from one chair to another possible. Due to its compact dimensions and foldable foot rest, the C-Max+ is easy to manoeuvre even on very narrow stair cases. For small, compact apartments with narrow doorways, the C-Max+ represents the ideal solution

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebinger Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Amtsgericht Stuttgart HRB 1006 . Sitz: Albstadt . Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

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Image /page/1/Picture/0 description: The image shows a logo with the letters "AAT" in white against a black background. The logo is a square with rounded corners. The letters "AAT" are stacked vertically, with "AA" on top and "T" on the bottom. The letters are in a bold, sans-serif font. The logo is simple and modern.

Scientific Concept: At the heart of the matter lies the patented climbing mechanism, which virtually climbs stairs all by itself. It also makes the C-Max+ particularly versatile and safe.

Function: Once the patient has seated and fastened the seat belt, the care attendant needs little physical power to handle the C-Max+. The C-Max+ is individually adjustable. Wheels make the transport on the floor easy. The battery-powered stair-climbing mechanism is usercontrolled with adjustable speed and climbing-direction. The attendant can also choose a single-step-mode alternatively to fluent climbing. A safety-brake ensures safe stops during the stair-climbing.

Image /page/1/Picture/3 description: The image is a composite of six different views of a stair climbing wheelchair. The top left image shows a person sitting in the wheelchair on a flat surface. The top middle image shows a person sitting in the wheelchair on a set of stairs. The top right image shows a close-up of the wheelchair's handle and controls. The bottom three images show close-ups of the wheelchair's wheels and suspension system as it navigates stairs.

C-Max+ ascends:

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

Amtsgericht Stuttgart HRB 1006 · Sitz: Albstadt · Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

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Image /page/2/Picture/0 description: The image shows a logo with the letters "AAT" in white against a black background. The background is a square with a rounded corner at the top right. The letters are stacked vertically, with "A" on top, followed by another "A", and then "T" at the bottom.

C-Max+ descends:

Image /page/2/Picture/2 description: The image contains three panels showing different parts of a machine. The first panel shows a wheel with an arrow pointing to the left. The second panel shows a handle with a control panel. The third panel shows a wheel with a support leg.

Image /page/2/Picture/3 description: This image shows the features of a device, with labels and numbers pointing to different parts. The device has an adjustable handle, an up/down switch, speed control, and an on/off switch. Other features include a quick pin, a port for a magnetic charger system, a helix cable, and a seat belt system. The image also shows the locking pin for the foot rest, the seat unit, the release lever, the foot belt, and the foot rest.

Intended use:

Powered patient stairway chair lift; Intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

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Amtsgericht Stuttgart HRB 1006 · Sitz: Albstadt · Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

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Image /page/3/Picture/0 description: The image shows a logo with the letters "AAT" in bold, white font. The letters are positioned in the lower-left corner of a black square. The upper-right corner of the square is rounded, giving it a modern and stylized appearance.

Indication for use:

Support for disabled seated persons i.e. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.

Performance Standards:

Non-clinical tests were performed to determine substantial equivalence. The tests were performed according to recognized standards for powered patient stairway chair lifts. These are the applicable standards:

• To demonstrate the device's general safety, we performed non-clinical tests . according to EN 12182: Technical aids for disabled persons-general requirements and test methods.
• . To demonstrate the device's safe function under different standardized climatic conditions, we performed non-clinical tests according to ISO 7176-9: Wheelchairs -Part 9: Climatic tests for electric wheelchairs.
• . To demonstrate the device's electrical safety, we performed non-clinical tests according to ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods
• To demonstrate the device's safety concerning flammability, we performed non-. clinical tests according to ISO 7176-16: Wheelchairs - Part 16: Resistance to ignition of upholstered parts -- Requirements and test methods
• . To demonstrate the device's electromagnetic-compatibility, we performed non-clinical tests according to ISQ 7176-21: Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
• To demonstrate the device's mechanical and functional safety, we performed non-. clinical tests according to ISO 7176-23: Wheelchairs - Part 23: Requirements and test methods for attendant-operated stair-climbing devices
• . To demonstrate the device's biocompatibility, we performed non-clinical tests according to ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

Amtsgericht Stuttgart HRB 1006 - Sitz: Albstadt · Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

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Image /page/4/Picture/0 description: The image shows a logo with the letters "AAT" in bold, white font against a black square. The top-right corner of the square is rounded. The letters are stacked vertically, with "AA" on top and "T" below. The logo has a simple, modern design.

Comparison to legally marketed device (Substantial Equivalence):

The c-max+ (plus) is essentially equivalent in intended use, design and function to the c-max by AAT Alber Antriebstechnik GmbH (K103122).

| | c-max+ (plus) | c-max (K103122)
Predicate device |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Same but the use on winding
stairs is excluded | support for disabled seated
persons e.g. with ambulatory
impairments, including people
with spinal cord injury, spina
bifida, cerebral palsy, multiple
sclerosis, muscular dystrophy,
polio, rheumatism, etc. to move
from one level to another. |
| Manual wheelchair
accommodation | same | Integrated seating-unit. No
wheelchair adaption |
| Accessories /
Options | Head rest, seat belts, different
footrests; power charger for the
car, magnetic charging system | Head rest, seat belts, different
footrests; power charger for the
car |
| Stairway
Configuration | Straight and U-turn curves.
Up to 8" max. step-height.
Stairs must be in good condition.
Interior/exterior. Most stairway
material types | Curves, spiral turns.
Up to 9" max. step-height.
Stairs must be in good condition.
Interior/exterior. Most stairway
material types |
| Level of operator
difficulty | same | Requires some coordination.
Depends on rider weight, number
of stairs and operator ability.
Automatic braking. |
| Portability for
Travel | Breaks down into 3 parts,
heaviest part is 110 lbs. | Breaks down into 4 parts,
heaviest part is 37 lbs. |
| | Statement: due to its ability to
carry a higher load the frame
design is more rigid. | |
| Performance
Max. Load | 300 kg | 140 / 160 kg |
| steps | Approx. 300 | Approx. 375 |
| speed | 3-8 steps / minute
continually adjustable | 8 - 23 steps / minute
continually adjustable |
| | Statement: due to its ability to
carry a higher load, it is slower
than the p.d. | |
| Frame/chassis | Reinforced rigid metal profile | Rigid metal profile |
| Technical data | | |
| Height | 1490 - 1775 mm | 1090 - 1400 mm |
| Width | 527 mm | 440 - 485 mm |
| Total weight | 79.3 kg | 33,4 kg |
| Power supply | | |
| | | rechargeable |
| battery charger | same | (input) 90-240 V AC
(output) 24 V DC |
| motor | same | 24V / 275 W / DC |

The Chart below summarizes the similarities and differences:

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

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Image /page/5/Picture/0 description: The image shows a logo with the letters "AAT" in bold, white font against a black background. The background is a square with the upper right corner rounded off. The letters are stacked vertically, with "AA" on top and "T" below. The logo is simple and modern, with a focus on the acronym.

Analysis on the differences:

• . The main difference between the subject device C-Max+ und the predicate device C-Max is its max. load. The C-Max+ can carry twice as much as the predicate device. Due to this higher performance, the C-max+ (plus) has a reinforced structure that makes him stronger and slightly heavier and slower.
• Due to its ability to carry a higher load, it is slower than the predicate device. The . speed difference doesn't cause any safety problems.
• . The fact that the c-max+ total weight is way higher than the c-max's one is only due to the possibility of being able to carry a higher max. Ioad. The frame is more rigid. The weight difference doesn't cause any safety problems.

Quality Assurance and Manufacturing Controls:

AAT Alber Antriebstechnik GmbH operates to an established and certified quality management system according to ISO 9001, and ISO 13485.

Conclusion:

The subject device C-Max+ is as safe, as effective, and performs as well as the predicate device but with a higher max. load. The performed non-clinical tests demonstrate the safety of the subject device's performance, electricity, electromagnetic-compatibility, mechanical strength and durability, flammability and biological/toxicological aspects.

Sincerely.

AAT Alber Antriebstechnik GmbH

Michael Vent

p.p. Stefanie D. Bankston Official Correspondent for AAT Alber Antriebstechnik GmbH

SD

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH . Ehestetter Weg 11 . D-72458 Albstadt-Ebingen Tel. [phone] · Fax [phone] · [e-mail] · www.aat-online.de Postfach 100 560 - D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

Amtsgericht Stuttgart HRB 1006 · Sitz: Albstadt · Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2014

AAT Alber Antriebstechnik GmbH c/o Stefanie D. Bankston BEO MedConsulting Berlin GmbH Texas Office 3001 Ferndale Dr. League City. TX 77573

Re: K130864

Trade/Device Name: c-max+ (plus) Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: December 3. 2013 Received: December 27, 2013

Dear Ms. Bankston:

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

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Page 2 - Stefanie D. Bankston

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 [phone] or [phone] 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Carlos 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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Indications for Use

510(k) Number (if known) K130864

Device Name c-max+ (plus)

Indications for Use (Describe)

The product c-max+ (plus) offers motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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."