(11 days)
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Not Found
No
The summary describes a motorized stairlift and does not mention any AI or ML capabilities.
Yes
The device is intended for "medical purposes" to assist in the transfer of patients or mobility-impaired persons, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition or disability.
No
Explanation: The device is described as a "Powered Patient Transport" or "Stairway Chairlift" intended to assist transfers up and down stairs. There is no mention of it being used to diagnose conditions or processes.
No
The device description clearly identifies it as a "motorized device" and a "Powered Patient Transport," indicating it is a hardware device with a motor and mechanical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Powered Patient Transport" or "Stairway Chairlift" intended to "assist transfers of patients, or mobility-impaired persons, up and down flights of stairs." This describes a physical assistance device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing laboratory tests
The device's function is purely mechanical and related to patient mobility and transfer.
N/A
Intended Use / Indications for Use
The Bruno Electra-Ride™, Model Sre-1540 and Electra-Ride™ II, Model SRE-1550, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairliff. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.
Product codes
ILK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
DEC 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard A. Keller Product Development Manager Bruno Independent Living Aids, Inc. 1780 Executive Drive P.O. Box 84 Oconomowoc, WI 53066
Re: K033752
K033752
Trade/Device Name: Bruno Electra-Ride", Model SRE-1540 and Electra-Ride'" II, Model SRE-1550 Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Codes: ILK Dated: November 24, 2003 Received: December 1, 2003
Dear Mr. Keller:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) to togened the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food. Drug. de necs that have been require approval of a premarket approval application (PMA). and Cosmetion (110) (110) that to nevice, subject to the general controls provisions of the Act. The I ou may, increase, inities of the Act include requirements for annual registration, listing of general controls proficturing 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intact a wond regulations administered by other Federal agencies. You must or any I edelar statutes and equirements, 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.
1
Page 2 - Mr. Richard A. Keller
This letter will allow you to begin marketing your device as described in your Scction 510(k) This letter will anow you to orgin maneting your antial equivalence of your device to a legally prematication: THC BTT 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 If you desire specific acrioliance at (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Companies market notification" (21CFR Part 807.97). You may oblain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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,
Mark A. Milkein
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
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bruno Electra-Ride™, Model SRE-1540 and Electra-Ride™ II, Model SRE-1550
Indications for Use:
The Bruno Electra-Ride™, Model Sre-1540 and Electra-Ride™ II, Model SRE-1550, is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairliff. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use ﮯ (Per 21 CFR 801.109)
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