EASYSTAND BANTAM MEDIUM

K123834 · Altimate Medical, Inc. · INO · Aug 13, 2013 · Physical Medicine

Device Facts

• Record ID: K123834
• Device Name: EASYSTAND BANTAM MEDIUM
• Applicant: Altimate Medical, Inc.
• Product Code: INO · Physical Medicine
• Decision Date: Aug 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing up to 200 lbs.

Device Story

EasyStand Bantam Medium is a sit-to-stand standing frame for indoor use; supports users with physical disabilities in weight-bearing standing position; offers optional supine positioning. Device features manual hydraulic lift or optional battery-powered linear actuator motor activated by hand pendant. Optional Shadow Tray serves as desk/workstation in seated or standing positions. Used in home or clinical settings; operated by patient or caregiver. Device assists users in rising from seated to standing position; provides method for body exercise. Benefits include improved ability to achieve standing position and weight-bearing support.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included mechanical strength, electrical safety, and performance testing per IEC 60601-1 (2nd and 3rd editions), IEC 60601-1-11, IEC 60601-1-2, and BS EN 12182:1999.

Technological Characteristics

Electric positioning chair/standing frame. Materials: unspecified. Energy source: manual hydraulic cylinder or battery-powered linear actuator motor. Connectivity: none. Dimensions: accommodates heights 48"-66" and weights up to 200 lbs. Standards: IEC 60601-1 (3rd Ed), CSA C22.2#60601-1, IEC 60601-1-11, IEC 60601-1-2, BS EN 12182:1999. Software: none (electromechanical control).

Indications for Use

Indicated for persons with difficulty rising from seated to standing position, weighing up to 200 lbs.

Regulatory Classification

Identification

An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.

Special Controls

(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable; (9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and (10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.

Predicate Devices

• Altimate Medical EasyStand Bantam (K091242)

Submission Summary (Full Text)

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**AUG 1 3 2013**

## 510(K) SUMMARY FOR ALTIMATE MEDICAL'S EASYSTAND BANTAM MEDIUM

This summary of 510(K) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CRF 807.92

The assigned 510(k) number is_K123834

Date: December 12, 2012

·

- Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190
- Manufacturer: Altimate Medical Registration No. 2183634 262 W. First Street Morton, MN 56270

Telephone: [phone] Fax: [phone]

Contact Person: Mr. Bob Rogers

Trade Name: EasyStand Bantam Medium

Common Name: Electric Lift Chair

Classification Name: Chair, positioning, electric per 21 CFR 890.3110

Legally Marketed Predicate Device(s): Altimate Medical EasyStand Bantam: K091242 July 6, 2009

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Image /page/1/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a stylized font inside of an oval shape. Below the logo is the phrase "Yes, you can." in a smaller font.

Device Description: The EasyStand Bantam Medium is a standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is a sitto-stand stander with the option of supine positioning. The optional Shadow Tray supports the user from sitting to standing and can be used as a desk/workstation in the seated and /or standing position. The device offers two options to raise the seat, the standard nanual hydraulic lift or the optional Pow'r Up lift. The Bantam Medium accommodates most individuals within the height range of 48"-66" and up to 200 lbs.

Intended Use: To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing up to 200 lbs.

Substantial Equivalence: Products that are substantially equivalent to the Altimate Medical EasyStand Bantam Medium is the Altimate Medical EasyStand Bantam K091242, July 6, 2009.

The EasyStand Bantam Medium is comparable to the EasyStand Bantam in its intended use, construction and functionality. The intended use of providing support for persons in a standing position, providing a means for a person to rise from a seated to a fully standing position and offering a method of exercising the body remains the same between the two devices. Two of the lifting features are the same in both devices in that elevation is accomplished either manually by a user operated hydraulic oil cylinder or electrically by a battery powered linear actuator motor that is activated by a hand pendant.

The main difference between the two devices is as follows:

- -- The user population. The EasyStand Bantam Medium accommodates most individuals ranging in height from 48''- 66'' (122cm-168cm) and up to 200 lbs. (91kg). The Bantam EasyStand Extra Small and Small is intended for smaller individuals, including pediatrics (the extra small accommodates most individuals ranging in height from 28"- 40" (71cm-102cm) and up to 50 lbs. (23kg) and the small accommodates most individuals ranging in height from 36''-54" (91cm-137cm) and up to 100 lbs. (45kg).
- The EasyStand Bantam Medium has a single control handle that operates the functions associated with the supine option.
- The EasyStand Bantam Medium back angle adjustment is independent of the following arm and the tray.

Performance Standards: Although no performance standards or special controls have been developed for electric positioning chairs under Section 514 of the FD & C Act, Altimate Medical has chosen to test the EasyStand Bantam Medium against the following standards and the reports are enclosed herein:

- IEC 60601-1 (3rd Edition) and CSA C22.2#60601-1 (3rd Edition) for basic safety and . performance, including risk management;

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- IEC 60601-1 (2nd Edition) to address medical electrical equipment general requirements for . safety. The EasyStand Bantam Medium and predicate devices all meet IEC 60601-1 (200 Edition), including mechanical strength testing for the claimed weight capacities.
- . IEC 60601-1-11 to address specific requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment;
- IEC 60601-1-2 to address Class B emissions and immunity for non-life-supporting equipment; . and,
- . BS EN 12182:1999 to address safety requirements for medical electrical systems. Included in this test report, load testing results support EasyStand Bantam Medium substantial equivalency.

The results of these tests demonstrate and support a determination of substantial equivalence.

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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-002

Auqust 13, 2013

Altimate Medical, Inc. % Ms. Stacey Frank Director of Operations 262 West First Street Morton, MN 56270

Re: K123834

> Trade/Device Name: EasyStand Bantam Medium Regulation Number: 21 CFR 890.3110 Regulation Name: Electric Lift Chair Regulatory Class: Class II Product Code: INO Dated: July 2, 2013 Received: July 9, 2013

Dear Ms. Frank:

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.

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Page 2 - Ms. Stacey Frank

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-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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 vours.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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): K123834

Device Name: EasyStand Bantam Medium

Indications for Use: The Altimate Medical EasyStand Bantam Medium is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing up to 200lbs.

Prescription Use > (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)

## Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123834

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