(93 days)
Not Found
No
The description focuses on mechanical and electrical components and control mechanisms, with no mention of AI or ML.
No
The device is described as a powered patient transport to assist transfers of patients, not a device that treats or diagnoses a medical condition.
No
The device description clearly states it is a "powered patient transport" that assists transfers of patients up and down stairs. There is no mention of the device being used to diagnose any medical condition.
No
The device description clearly outlines physical hardware components including an upholstered chair assembly, truck assembly, track, and power source (AC or batteries/chargers). It is a physical device with mechanical and electrical components, not solely software.
Based on the provided information, the Merits E600 Series Stair Lift System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist in the physical transfer of patients or mobility-impaired persons up and down stairs. This is a mechanical function related to mobility and patient handling.
- Device Description: The description details a mechanical system with a chair, track, and motor. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Measuring biomarkers
The device is clearly a medical device intended for patient transport and mobility assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Merits E600 Series Stair Lift System is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. 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
The Merits E600 Series Stair Lift basically consists of an upholstered chair assembly, a truck assembly, and a maximum 16 feet track. The chair and truck assemblies constitute the platform moving up and down along the inclined track. The entire lift is installed in either side of the indoor stairway in a private residence. All models share the same specifications such as driving means and safeties other than the power source. The Model E600 uses the AC power as its power source while the Model E601 employs the batteries and chargers. The operation of the lift is controlled by a momentary rocker control under one armrest and two infrared remote controls. The move of the lift will stop immediately when the button or switch of the controls is released.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bruno Electra-Ride II Indoor Straight Rail Stairlift Model SRE-1550 (K033752)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K073/10
510(k) SUMMARY
- 9 1 Trade/Proprietary Name: Merits E600 Series Stair Lift
- 9.2 Common/Usual Name: Stairway Chairlift
FEB - 6
CUN
- 9.3 Classification Name: Powered patient transport
- 9.4 Comparison to Currently Marketed Devices
The Merits E600 Series Stair Lift is substantially equivalent to the Bruno Electra-Ride II Indoor Straight Rail Stairlift Model SRE-1550 (K033752)
તે રે Device Description
The Merits E600 Series Stair Lift basically consists of an upholstered chair assembly, a truck assembly, and a maximum 16 feet track. The chair and truck assemblies constitute the platform moving up and down along the inclined track. The entire lift is installed in either side of the indoor stairway in a private residence. All models share the same specifications such as driving means and safeties other than the power source. The Model E600 uses the AC power as its power source while the Model E601 employs the batteries and chargers. The operation of the lift is controlled by a momentary rocker control under one armrest and two infrared remote controls. The move of the lift will stop immediately when the button or switch of the controls is released.
તે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ Intended use
The Merits E600 Series Stair Lift System is a Powered Patient Transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobilityimpaired persons, up and down flights of stairs.
9.7 Technological Characteristics
Merits E600 Series Stair Lift is equivalent in functions to the legally marketed predicate device. They all use rack and pinion as its driving and support means. This kind of means offers self-locking mechanism to prevent uncontrolled movement. The application of rack and pinion is well-established and has been extensively used by other legally marketed products. There is no technology difference between the two. For the remote control, Merits E600 Series Stair Lift adopts infrared light to achieve the controlling needs. Unlike radio signals used by the predicate, the infrared technology eliminates the possible interference or damage to the environment. The technology is not only safer than the radio frequency technology but also widely used by other products.
9.8 Performance Data
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
1
9.9 Conclusion
Based on the design, performance specifications, testing, and intended use, the Merits E600 Series Stair Lift is substantially equivalent to the legally marketed device, Bruno Electra-Ride II Indoor Straight Rail Stairlift Model SRE-1550 (K033752)
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
FEB - 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Merits Health Products Co., LTD. c/o Mr. Steve Chao No. 9, Rd. 36, Taichung Industrial Park Taichung City China (Taiwan) 40768
Re: K073110 Trade/Device Name: Merits E600 Series Stair Lift Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: January 4, 2008 Received: January 4, 2008
Dear Mr. Chao:
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.
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.
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Page 2 - Mr. Steve Chao
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millhussen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number:
Device Name: Merits E600 Series Stair Lift
Indications For Use:
The Merits E600 Series Stair Lift System is a powered patient transport, also commonly known as a Stairway Chairlift, or Stairlift. It is a motorized device intended for medical purposes to assist transfers of patients, or mobility-impaired persons, up and down flights of stairs.
| 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)
(Division Sign-Off)
Concurrence of CDRH, Office of Division of General, Restorative, and Neurological Devices
| 510(k) Number | 11073 |
|---|---|
| --------------- | ------- |
11-15-2019