(29 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical safety standards, with no mention of AI or ML technologies.
No
This device assists with a physical movement (rising from a chair) but does not treat, diagnose, cure, or prevent a disease or condition, which are characteristics of a therapeutic device. It is more of an assistive living aid.
No
The device is described as an electrically powered, motor-driven chair designed to assist individuals with rising from a seated to a standing position. Its function is purely mechanical assistance, not to diagnose any medical condition or disease.
No
The device description clearly outlines physical components like a steel frame, upholstered chair assembly, and motorized lift actuator, indicating it is a hardware device with electrical and mechanical components, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist individuals with physical difficulty in rising from a seated to a standing position. This is a physical assistance function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical, electrically powered chair designed for physical support and movement. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in the body.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on biological analysis.
The device is clearly a medical device providing physical assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Berkline Model Easy Lift Out Chair to assist persons who have difficulty rising from a seated position to a standing position.
The intended use of the Berkline Model Easy Lift Series Lift Out Chair to assist persons, who have difficulty rising from a seated position to a standing position. ficulty rising from a seated position to a standing position.
Product codes
INO
Device Description
The Berkline Model LC Series Lift Chairs are electrically powered, motor driven devices designed for use in the home or an extended care environment. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position once seated.
The chairs are consist primarily of welded steel frame, an upholstered chair assembly, and motorized lift actuator. A hand held pendant type control is used activate the drive motor and raise or lower the chair to the desired position. Model numbers and physical dimensions vary with the type of aesthetic style of the chair.
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
home or an extended care environment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Berkline Model LC Lift Chairs have been tested to and meet:
- U.L. 1647 "Standard for Motor-Operated Massage and Exercise Machines".
- U.L. 73 "Standard for Motor Operated Appliances"
The upholstery used has been tested to and meets: - California TB 117 (Flammability)
- UFAC Fabric Classification (Class I) .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 890.3110 Electric positioning chair.
(a)
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.(b)
Classification. Class II. The electric positioning chair 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:(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.
0
NOV 1 9 2002
510(k) SUMMARY
Berkline Corporation's Model LC Series Lift Out Chairs
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Berkline Corporation One Berkline Drive Morristown, TN 37813 Phone: (423) 585-1500 Facsimile: (423) 585- 1760
Contact Person: David Popkin Senior Vice President, Legal services
Date Prepared: September 24, 2002
Name of Device and Name/Address of Sponsor
Model Easy Lift Series Lift Out Chairs
Berkline Corporation One Berkline Drive Morristown, Tennessee Phone: (423) 585- 1500 Facsimile: (423) 5856- 1760
Common or Usual Name
Lift Out Chair
Classification Name
Chair, Electric, Positioning
Predicate Devices
Pride Health Care Inc. TMR48 Lift Chair (K953342) and Invacare Model LC Lift Chair (K002171).
Intended Use
The intended use of the Berkline Model Easy Lift Out Chair to assist persons who have difficulty rising from a seated position to a standing position.
1
Technological Characteristics and Substantial Equivalence
A. Device Description
The Berkline Model LC Series Lift Chairs are electrically powered, motor driven devices designed for use in the home or an extended care environment. Their intended function and use is to raise persons from a seated position to a standing position. They are designed for use by elderly or physically challenged individuals who have difficulty rising to a standing position once seated.
The chairs are consist primarily of welded steel frame, an upholstered chair assembly, and motorized lift actuator. A hand held pendant type control is used activate the drive motor and raise or lower the chair to the desired position. Model numbers and physical dimensions vary with the type of aesthetic style of the chair.
B. Substantial Equivalence
The Berkline Model LC Series Lift Out Chairs are substantially equivalent to Pride Health Care Inc. TMR48 Lift Chair (K953342) and Invacare Corporation Model LC Series Lift Chair (K002171). Each of these products are electrically powered, motor driven, lift out chairs with the same intended function and use which is to assist elderly and/or physically challenged persons to arise from a seated position to a standing position.
PERFORMANCE DATA
The Berkline Model LC Lift Chairs have been tested to and meet:
- U.L. 1647 "Standard for Motor-Operated Massage and Exercise Machines". ●
- · U.L. 73 "Standard for Motor Operated Appliances"
The upholstery used has been tested to and meets:
- California TB 117 (Flammability) ●
- UFAC Fabric Classification (Class I) .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a human figure.
NOV. 1. 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Berkline Corporation David Popkin Senior Vice President, Legal Services One Berkline Drive Morristown, Tennessee 37813
Re: K023521
Trade/Device Name: Easy Life Lift Chair Regulation Number: 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: October 1. 2002 Received: October 21, 2002
Dear Mr. Popkin:
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. Iisting 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.
3
Page 2 – Mr. David Popkin
. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Mark A. Mellema
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): TBD
.
Device Name: Berkline LLC Easy Lift Electric Positioning Chair .
·
Indications For Use: The intended use of the Berkline Model Easy Lift Series Lift Out Chair to assist persons, who have difficulty rising from a seated position to a standing position. ficulty rising from a seated position to a standing position. .
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
for Mark A Milliken
(Division Signer)
(Optional Format 1-2-96)
Dative
a