(243 days)
Not Found
No
The description focuses on mechanical and electrical components for lift assistance, with no mention of AI or ML.
No.
The device's intended use is to provide lift assistance for persons who have difficulty rising, which is a supportive function rather than a therapeutic one designed to treat or cure a medical condition.
No
The device's intended use is to provide lift assistance, not to diagnose any medical condition.
No
The device description clearly outlines physical components such as a welded steel frame, upholstery fabric, foam, a DC motor/actuator, and a hand-held control device, indicating it is a hardware device with electrical components, not software-only.
Based on the provided information, the Dalton Lift Chair, Model LC-106 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide physical assistance for rising from a seated position. This is a mechanical function related to mobility, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical chair with a lifting mechanism, motor, and hand control. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying diseases, conditions, etc.)
The device is clearly a medical device intended for physical assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Product codes
INO
Device Description
The Dalton Lift Chair, Model LC-106 is intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. It uses standard AC power from an electrical outlet. The device is mainly made of a welded steel frame, upholstery fabric and foam. The chair is assembled to welded steel lifting frame mechanism having a 24V DC motor/actuator powered by AC power from an electrical outlet. A hand-held control device engages the actuator to position the chair to recline, sitting, or standing position.
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 proposed Dalton Lift Chair LC-106 was evaluated per IEC 60601-1:1988/A1:1991/A2:1995 for basic safety. The Electromagnetic Compatibility of the device was evaluated per IEC 60601-1-2. All tests were completed successfully.
The Dalton Lift Chair LC-106 was tested per standard 'California Technical Bulletin No. 117: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture'.
The Upholstery Fabric (Chair Cover) of the Dalton Lift Chair LC-106 that may come in contact with patients is biocompatible. The material was evaluated for Cytotoxicity per ISO 10993-5 and for Skin Irritation and Dermal Sensitization per ISO 10993-10.
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
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
DALTON INSTRUMENT CORP
16300 Addison Road, Suite 120 Addison, TX 75001
Lift Chair
Ph: 469-522-1200 Fax: 469-522-1202
LC-106 510(K) APPLICATION
Section 5
510(k) Summary
(Per 21 CFR 807.92)
Submitter's Name and Contact Information: 1.
Mrs. Mei Lein Dalton Instrument Corp. 16300 Addison Road, Suite 120 Addison, TX 75001 Email: daltonint@gmail.com Phone: (469) 522-1200 Fax: (469) 522-1202
Summary Preparation Date: 20 February 2014
2. Device Identification:
| Proprietary Name: | Dalton Lift Chair, Model LC-106 |
|---|---|
| Generic Name: | Electric Positioning Chair |
| Classification: | Class II |
| Product Code: | INO |
| Regulation Number: | 21 CFR 890.3110 |
| Review Panel Code: | Physical Medicine |
3. Predicate Device
The proposed 'Dalton Lift Chair, LC-106' is substantially equivalent to the Lift Chair Model C5 manufactured by Pride Mobility Products Corp., previously cleared under K070950.
1
Description of Device 4.
The Dalton Lift Chair, Model LC-106 is intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. It uses standard AC power from an electrical outlet. The device is mainly made of a welded steel frame, upholstery fabric and foam. The chair is assembled to welded steel lifting frame mechanism having a 24V DC motor/actuator powered by AC power from an electrical outlet. A hand-held control device engages the actuator to position the chair to recline, sitting, or standing position.
5. Indications for Use
The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Summary of Similar Technological Characteristics 6.
Dalton Instrument Corp. 'Dalton Lift Chair, LC-106' and predicate device 'Lift Chair C5' (K070950) are intended to provide lift assistance for persons who have difficulty rising from a seated position to a standing position. They have the same intended use and indications for use. Their operating principle and technological characteristics are also comparable, as outlined in the following table:
| Characteristics /
Features | Subject Device | Predicate Device
K070950 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dalton Lift Chair, Model LC-106
(Dalton Instrument Corp.) | Lift Chair, Model C5
(Pride Mobility Products Corp.) |
| Classification | Class II | Class II |
| Product Code
Regulation | INO
21 CFR 890.3110 | INO
21 CFR 890.3110 |
| Indications for Use | The intended use of the Dalton
Lift Chair, Model LC-106 is to
provide lift assistance for persons
who have difficulty rising from a
seated position to a standing
position. | The Intended Use of the
Pride Mobility C5 Lift Chair
is to provide lift assistance
for persons who have
difficulty rising from a
seated position to a
standing position. |
| Design / Construction | | |
| Basic Platform | Welded Steel Lifting Frame | Welded Steel Lifting Frame |
| Drive Mechanism /
Actuator | Delta Drive DC 24V
(manufactured by Okin Refined
Electric Technology Co. Ltd.) | Delta Drive DC 24V
(manufactured by Okin Refined
Electric Technology Co. Ltd.) |
| Command Input | Hand-held Control device to
operate the various functions of
the lift chair, such as positioning
to recline, sitting or standing
position | Hand-held Control device to
operate the various functions of
the lift chair, such as positioning
to recline, sitting or standing
position |
| Upholstery Fabric
(Chair Cover) | Made of Microsuede / Microfiber
(Polyester material) | Made of Polyester material |
2
| Characteristics /
Features | Subject Device | Predicate Device
K070950 |
|---------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| | Dalton Lift Chair, Model LC-106
(Dalton Instrument Corp.) | Lift Chair, Model C5
(Pride Mobility Products Corp.) |
| Chair Cushion | Made of Foam
(Polyurethane material) | Made of Foam
(Polyurethane material) |
| General and Technical
Specifications | | |
| · Maximum Duty cycle
(Mode of operation) | 2 min ON / 18 min OFF | 2 min ON / 18 min OFF |
| · Power Requirements | 100-240 VAC, 50/60 Hz | 100-240 VAC, 50/60 Hz |
| · Operating
Temperature | 10°C (50°F) to 40°C (104°F) | 10°C (50°F) to 40°C (104°F) |
| · Weight Capacity | 235 lbs (107 kg) | 325 lbs (147 kg) |
| · Weight of Lift Chair | 133 lbs | 133 lbs |
| · Maximum Tilt Angle | 45 Degree | Not Specified |
| · Seat Height | 19" (483 mm) | 18" (457 mm) |
| · Seat Width | 20" (508 mm) | 19" (483 mm) |
| · Seat Depth | 20" (508 mm) | 20" (508 mm) |
| · Overall Width | 33" (838 mm) | 32.75" (832 mm) |
| · Overall Height | 43" (1092 mm) | Not specified |
| · Arm Height | 25.6" (650 mm) | Not specified |
| · Overall Reclined
Depth | 69" (1753 mm) | Not specified |
| · Overall Upright
Depth | 34.6" (879 mm) | Not specified |
7. Non-Clinical Testing
The proposed Dalton Lift Chair LC-106 was evaluated per IEC 60601-1:1988/A1:1991/A2:1995 for basic safety. The Electromagnetic Compatibility of the device was evaluated per IEC 60601-1-2. All tests were completed successfully.
The Dalton Lift Chair LC-106 was tested per standard 'California Technical Bulletin No. 117: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture'.
The Upholstery Fabric (Chair Cover) of the Dalton Lift Chair LC-106 that may come in contact with patients is biocompatible. The material was evaluated for Cytotoxicity per ISO 10993-5 and for Skin Irritation and Dermal Sensitization per ISO 10993-10.
8. Clinical Testing
The submission does not rely on any clinical data; therefore no clinical testing was performed.
3
Conclusion: 9.
Based on design, technological characteristics, performance specifications and non-clinical bench testing information provided in the submission; the proposed Dalton Lift Chair LC-106 is substantially equivalent to the predicate device, and does not raise any new concerns of safety and effectiveness.
4
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Centrol Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2014
Dalton Instrument Corporation c/o Ms. Mei Lein 16300 Addison Road, Suite 120 Addison, TX 75001
Re: K131909
Trade/Device Name: Dalton Lift Chair. Model LC-106 Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO Dated: January 10. 2014 Received: January 14, 2014
Dear Ms. Lein:
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
5
Page 2 - Ms. Mei Lein
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 tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevicesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K 131909
Device Name Dalton Lift Chair, Model LC-106
Indications for Use (Describe)
The intended use of the Dalton Lift Chair, Model LC-106 is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
PSC Publishing Services (30) } 443-6740
7
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