(10 days)
Not Found
No
The summary describes a standard powered wheelchair with positional adjustments controlled by the user via hand controls. There is no mention of AI, ML, or any automated decision-making or learning capabilities.
No
The device is a mobility aid designed to assist individuals with various conditions in changing positions and moving around. While it addresses functional limitations, it does not directly treat or cure a disease or condition, which is a characteristic of a therapeutic device.
No
The device description indicates it is a powered wheelchair designed for mobility and changing body positions. It aids individuals with various conditions in standing and moving, but it does not perform any diagnostic functions like detecting, monitoring, or analyzing physiological states or diseases.
No
The device description clearly describes a physical, battery-operated powered wheelchair with a base, wheels, seat, and hand controls. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to provide mobility and change the position of individuals who cannot stand on their own. This is a physical function, not a diagnostic one.
- Device Description: The description details a powered wheelchair with features for changing position and providing mobility. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
- Performance Studies: The performance studies mentioned are related to electrical and mechanical safety and performance of a wheelchair, not diagnostic accuracy.
In summary, the ALILIFE Stand Up Powered Wheelchair, HC-300 is a medical device designed for mobility and positioning, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Product codes
IPL
Device Description
The ALILIFE Stand Up Powered Wheelchair, HC-300 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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)
Performance Testing: EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers – requirements and test methods)
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
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a white abstract design on a black background. The design features a combination of straight lines and rounded shapes. The shapes are arranged in a way that creates a sense of depth and movement within the composition.
SEP - 9 2005
ALILIFE TECHNOLOGICAL CO., LTD. 77 Goneve Rd. Dah City Taichung County 412 Taiwan. ROG Fax 886-4-2401-4401 161 880-4-2492-6388 Franail alife a alihle comhttp://www.alilife.com
510(k) SUMMARY "
Submitter's Name: ALILIFE Technological Co., Ltd.
NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C.
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
August 23, 2005
ALILIFE Stand Up Powered Wheelchair, HC-300 Standing Wheelchair Wheelchair, Standup, Class II, 21 CFR 890.3900
Indications for Use:
The device is a product which change people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Description of the device:
The ALILIFE Stand Up Powered Wheelchair, HC-300 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with The movement of the Wheelchair is controlled by the rider who uses hand a seat. controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers – requirements and test methods)
Legally marketed device for substantial equivalence comparison:
COMFORT Standing Wheelchair HERO 1 (K031621)
1
2/2
Image /page/1/Picture/1 description: The image shows the logo for Alilife. The logo consists of a square with a stylized triangle inside of it. Below the square is the word "ALILIFE" in all capital letters.
ALILIFE TECHNOLOGICAL CO., LTD. No 77 Gongve Rd Dali City Taichung County 412 Taiwan ROC Tel 886-4-2492-6288 - Fax 886-4-2401-4401 E-mail alifife a alifite com - http - www alilife com
Summary for substantial equivalence comparison:
Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The two devices used the same type of armrest. Back upholstery material is also the The electronic control systems between the two devices are same, same fabric. Penny and Giles. Besides, the two devices use the same supplier for battery and recharge which are all passed by the UL certificated.
The major differences existing are the overall dimension, the size of tires, and the weight limit is differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
SEP - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Ke-Min Jen Official Correspondent Alilife Technological Co., Ltd. No. 58 Fu-Chiun Street Hsin Chu City, Taiwan 30067 China
Re: K052375
K032373
Trade/Device Name: ALILIFE Stand Up Powered Wheelchair, HC-300 Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: August 23, 2005 Received: August 30, 2005
Dear Dr. Jen :
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave uctchimied the acres section to be vices marketed in interstate for use stated in the enclosure) to regally manced provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food commerce prior to May 28, 1970, the encentions with the provisions of the Federal Food, Drug, devices that have been reclassified in accreaned will of a premarket approval applications of the Act. The and Cosment Act (Act) that do not require approvial controls provisions of the Act. The Act. The You may, merelore, market the devices, basjon to the one of registration, listing of
general controls provisions of the Act include requirements for annual registration, list general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified ($cc above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I sacra. Its gaming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dr 3 issuation or our device complies with other requirements of the Act that IDA has made a decemmanding administered by other Federal agencies. You must or any it cacharded and regaranents, including, but not limited to: registration and listing (21 Compry with an the rive steen emons, one, as and manufacturing practice requirements as set CI K I at 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Ke-Min Jen
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil RPOglen
Mark N. Melkerson
Mark N. Melkerson Acting 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 ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: ALILIFE Stand Up Powered Wheelchair, HC-300 |
Indications for Use:
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Target Population:
For all individuals who need a standing Wheelchair with the possibility to change positions and who can not stand on their feet themselves such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Prescription Use __
AND/OR
Over-The-Counter Use √
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Col CDRH, Office of Device Evaluation (ODE) vision Sign-Off Division of General, Restorative, and Neurological Devices Page
510(k) Number K052375
the started and the count of the state of the state of the real of