(150 days)
Not Found
No
The description focuses on mechanical and ergonomic features, with no mention of AI or ML technologies.
No
The device is described as a stair lift intended for mechanical transport of a person up and down stairs, not for treating or diagnosing a medical condition.
No
The device is described as a stair lift primarily for transportation, and there is no indication that it diagnoses any medical condition or captures diagnostic data.
No
The device description clearly describes a physical, mechanical device (a stair lift) with hardware components like a seat, footrest, rail, and joystick control. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is a mechanical device designed to transport a person up and down stairs. It does not interact with or analyze any biological specimens.
- Intended Use: The intended use is clearly stated as "to mechanically transport one mobility impaired person... up and down curved stairs, indoors." This is a physical function, not a diagnostic one.
The device description and intended use clearly indicate that this is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.
Product codes (comma separated list FDA assigned to the subject device)
ILK
Device Description
Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house.
Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees.
The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.
Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home.
The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 890.5150 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
K121561
PAGE 1 OF 3
OCT 2 6 2012
510(k) SUMMARY as required by section 807.92(c)
| Submitted by: | ThyssenKrupp Accessibility BV
Van Utrechtweg 99
2921 LN Krimpen aan den Ijssel
The Netherlands |
|---------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Arnold van der Heiden
Mail: avanderheiden@tkacc.nl
Tel: +31 180 530900
Fax: +31 180 530901 |
| Date prepared: | 05/21/2012 |
| Trade Names: | FLOW2/ SWING |
| Common Device Name: | Battery Operated Stair Lift for Curved Stairs |
| Regulation Number | 890.5150 |
| Class | II |
| Product Code: | ILK |
| Submission | K121561 |
| Predicate Device: | Stair Lift BRUNO Independent Living Aids INC
K970927
CFR 890.5150 |
Promotional Product Description
Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house.
Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees.
The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion.
Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home.
1
The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.
Intended Use
- . ThyssenKrupp Accessibilty's Battery Operated Stair Lift is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.
Product Comparison Tables
Equivalent Technological Characteristics
| Bruno CRE-2110 Electra-Ride | ThyssenKrupp Accessibility Flow2 | |
|---|---|---|
| Standards | ASME 18.1, IEC 60601-1-2:2007 | ASME 18.1, IEC 60601-1-2:2007 |
| Application | Straight and Curved stairs | Straight and Curved stairs |
| Rated Load | 400 lb (181 kg) maximum | 275 lb (125 kg) maximum |
| Passengers | 1 | 1 |
| Power | 2 pieces 7AH 12 Battery | 2 pieces 7AH 12 Battery |
| Charger | 24VDC/ 2A | 24VDC/ 2A |
| Drive | Direct drive worm gear motor | Planetary motor with worm gear |
| Final Drive | 8dp gear rack with spur gear | Lasered rack and pinion |
| Braking | Dynamic, worm gear, el/mech brake | Dynamic, worm gear, el/mech brake |
| Call & Send | RF | RF |
| Supports | Anchored to stair thread | Anchored to stair thread |
| Angle | 50 degrees | 70 degrees |
| Speed | 0.13 m/s | 0.15 m/s |
| Track length | 15 m | 34 m |
| Location | Designed to contour of stairway | Designed to contour of stairway |
| Safety devices | Multiple | Multiple |
| Footrest | Folding type | Folding type |
| Seat | Folding type | Folding type |
Non Equivalent Technological Characteristics
| Bruno CRE-2110 Electra-Ride | ThyssenKrupp Accessibility Flow2 | |
|---|---|---|
| Control | 3 position momentary rocker switch | 3 position switched RF unit |
| Construction | Steel welded shape | Bended round steel tube 80mm |
| Leveling | Mechanically forced | Patented electronic leveling |
| Swiveling | End of rail | Patented "en route" swiveling |
2
Product Comparison Discussion
Bruno's Electra Ride and ThyssenKrupp Accessibility's Flow2 show substantial equivalence on most standard features and characteristics.
- Both products follow the contour of the stairway by a customer specific design, the . only difference in this aspect is that Bruno applies a steel welded shape while ThyssenKrupp uses a bended round steel tube.
- Both products provide levelling of the chair during the ride, the only difference in this . aspect is that the Bruno chair is forced mechanically in horizontal position while ThyssenKrupp applies a patented multiple sensor controlled electronic levelling system
- Both products provide swivelling of the chair for easy getting on and off the chair, the . only difference in this aspect is that ThyssenKrupp provides patented "en route" swivelling to allow installation at narrow staircases
ThyssenKrupp Accessibility's Flow2 mainly shows non equivalence with Bruno's Electra Ride on electronic control. The system - electronics included - is certified by ETL and Lift Institute as stated by the ETL Listing Report and Lift Institute Type Approval, based on international stair lift standards.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Thyssenkrupp Accessibility B.V. % Mr. Arnold Heiden Technical Advisor Van Utrechtweg 99 Krimpen aan den lissel Zuid-Holland, Netherlands 2921 LN
Re: K121561
Trade/Device Name: FLOW2 Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: ILK Dated: October 23, 2012 Received: October 25, 2012
OCT 26 2012
Dear Mr. Heiden:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Mr. Arnold Heiden
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark H. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ K121561
Device Name: FLOW2
Indications for Use:
ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.
NO Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and the same of the same of the same and the many of the many of the many comments of the many of the many of the many of the many of the many of the many of the many of the
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121561
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