(231 days)
Not Found
No
The device description and performance testing focus on mechanical aspects and adherence to wheelchair standards, with no mention of AI or ML.
No
The device provides mobility, which is an assistive function, not a therapeutic treatment. It does not actively treat or cure a medical condition.
No
The device is described as a "Shanghai Phoenix Mechanical Wheelchair" intended to "provide mobility to persons restricted to a seated position." There is no indication or description of it gathering or analyzing data to diagnose a condition.
No
The device description clearly outlines a physical, mechanical wheelchair with components like a base, wheels, seat, and upholstery, and the performance studies reference standards for physical wheelchair testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "medical purposes to provide mobility to persons restricted to a seated position." This describes a physical aid for mobility, not a device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a mechanical wheelchair with components like a base, wheels, seat, and upholstery. This aligns with a mobility device, not an IVD.
- 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 samples
- Providing diagnostic information
- Using reagents or assays
The information provided focuses on the physical characteristics, intended use for mobility, and performance testing related to the structural integrity and safety of a wheelchair.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes
IOR
Device Description
The Shanghai Phoenix Mechanical Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette. and match flame equivalent.
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)
Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards including:
- · ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
- · ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
- · ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.
- 1SO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 0 1998.
- · ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
- · ISO7176-11 Wheelchairs Part 11: Test dummies, 1992.
- @ ISO7176-13 Wheelchairs Part 13:Determination of coefficient of friction of test surfaces, 1989.
- · ISO7176-15 Wheelchairs Part 15:Requirements for information disclosure, documentation and labelling, 1996.
- . ISO7176-16 Wheelchairs - Part 16:Resistance to ignition of upholstered parts --Requirements and test methods, 1997.
- · ISO7176-22 Wheelchairs Part 22:Set-up procedures, 2000.
- · EN 12183 Manually propelled wheelchairs Requirements and test methods, 1999.
- · EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006.
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
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows a black and white drawing of a figure that appears to be a stylized bird or creature perched on a rectangular base. The creature has a flowing, almost ethereal quality, with lines suggesting feathers or fur. The base is marked with what looks like symbols or writing, adding to the image's enigmatic nature. The overall impression is one of a symbolic or heraldic emblem.
Shanghai Phoenix Medical Equipment CO., LTD. NO.188 Zhongfa Road.Zhujing Industrial Park.Jinshan District,Shanghai China Tel: 086-021-67221555 - Fax:086-021-67221999 E-mail:ph(@phoenixmed.com.cn
510(k) SUMMARY "
K130848
Submitter's Name: Shanghai Phoenix Medical Equipment Co., Ltd. No. 188 Zhongfa Road,Zhujikng Industrial Park, Jinshan District, Shanghai, China, 201500
Date summary prepared:
Device Name:
Proprietary Name: Model name:
Common or Usual Name:
Classification Name:
Regulation Number:
Product Code:
Shanghai Phoenix Mechanical Wheelchair PHW954LGC for Aluminum Framework PHW902BC for Steel Framework Mechanical Wheelchair Mechanical Wheelchair, Class I. 21 CFR 890.3850 IOR
Contact person:
Dr. JEN. KE-MIN
FAX: +886-3-5209783 TEL: +886-3-5208829
Email: ceirs.jen@msa.hinet.net
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The Shanghai Phoenix Mechanical Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette. and match flame equivalent.
Literature for Performance Testing:
Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards including:
- · ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
- · ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
- · ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008.
NOV 1 2 2013
March 18. 2013
1
Image /page/1/Picture/0 description: The image shows a black and white drawing of a figure. The figure appears to be a person sitting on a platform. The person is hunched over, and their head is tilted down. The platform has a rectangular shape with some markings on it. The drawing is simple and lacks detail.
- 1SO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 0 1998.
- · ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998.
- · ISO7176-11 Wheelchairs Part 11: Test dummies, 1992.
- @ ISO7176-13 Wheelchairs Part 13:Determination of coefficient of friction of test surfaces, 1989.
- · ISO7176-15 Wheelchairs Part 15:Requirements for information disclosure, documentation and labelling, 1996.
- . ISO7176-16 Wheelchairs - Part 16:Resistance to ignition of upholstered parts --Requirements and test methods, 1997.
- · ISO7176-22 Wheelchairs Part 22:Set-up procedures, 2000.
- · EN 12183 Manually propelled wheelchairs Requirements and test methods, 1999.
- · EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006.
Materials used in the main supporting features of the device:
- · 7000 series aluminum for PHW954LGC Aluminum Framework.
- @ High-Quality SPCC Steel Pipe for PHW902BC Steel Framework.
Material in contact with patients:
- PVC Leather for seat.
Legally marketed device for substantial equivalence comparison:
KAIYANG Aluminum Wheelchair (K101998)
Summary for substantial equivalence:
All of the features, except for the sizes and supporting material, are the same. The small differences of the sizes between the two devices do not affect the safety or effectiveness. Furthermore, the steel material for the subject device shows more strength than the aluminum material used for the predicate device. Thus the subject device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows a black and white drawing of a crest or emblem. The emblem features a stylized bird-like figure perched atop a rectangular base. The base appears to have some markings or symbols on it, although they are not clearly legible due to the image quality. The overall design is simple and somewhat abstract.
Shanghai Phoenix Medical Equipment CO., LTD.
NO.188 Zhongfa Road.Zhujing Industrial Park.Jinshan District.Shanghai China
Tel: 086-021-672215555 | Fax:086-021-672215999
E-mail:ph@phocnixmed.com.cn
Comparison Table
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE |
|---|---|---|
| BRAND NAME | KAIYANG | Shanghai Phoenix |
| MANUFACTURER | Guangdong Kaiyang Medical | |
| Technology Co., Ltd. | Shanghai Phoenix Medical | |
| Equipment Co., Ltd. | ||
| MODEL NO | KAIYANG Aluminum Wheelchair | Mechanical Wheelchair |
| PHW954LGC Aluminum Framework | ||
| PHW902BC Steel Framework | ||
| 510K NO | K101998 | K130848 |
| INTENDED USE | The device is intended for | |
| medical purposes to provide | ||
| mobility to persons restricted | ||
| to a sitting position. | SAME | |
| FRAME | ||
| Seat width | 18.1"~25.1" | 18.1" |
| Cross brace | YES | SAME |
| Seat height | 16.2" | 20.0" |
| Full length | 1050 mm | 1180 mm |
| Full width | 650 mm | 670 mm |
| Full height | 920 mm | 920 mm |
| Backrest height | un-adjustable | SAME |
| Reclining backrest | fixed | SAME |
| Seat sling | padded nylon | SAME |
| Frame colors | Black, Blue | Silver white |
| ARMREST | ||
| Arm pad | Padded | SAME |
| Flip back | YES, detachable | SAME |
| Height-adjustable | adjustable | SAME |
| HANGERS | ||
| Swing-away | YES | SAME |
| Elevating leg rest | YES | SAME |
| Articulating leg rest | YES | SAME |
| Footplate style | Padded | SAME |
| Heel loop | No | SAME |
| Footrest angle | 10° | SAME |
| REAR AXLE | ||
| Offset axle | YES | SAME |
| Quick release axle | YES | SAME |
| ITEMS | PREDICATE DEVICE | SUBJECT DEVICE |
| REAR WHEEL | ||
| Size | ||
| Tire type | ||
| Handrim material | 7.5" | |
| Pneumatic | ||
| Aluminum composite | 24" | |
| Pneumatic | ||
| Aluminum composite | ||
| CASTERS | ||
| Size | ||
| Tire type | 5~8" | |
| Solid | 7" | |
| Solid | ||
| WHEEL LOCK | Pull-to-Lock | SAME |
| WEIGHT CAPACITY | 100 Kgs / 220 lbs | SAME |
| WEIGHT OF CHAIR | 17.5~21 kgs | SAME |
| (19.0 kgs / 41.8 lbs ) | ||
| STABILITY TEST | ISO 7176 series standards | SAME |
| WARRANTY | 12 months for the main parts | |
| ( The chair side frames are | ||
| guaranteed for 5 years from | ||
| the date of purchase. ) | SAME | |
| OPTIONAL ACCESSORIES | ||
| Anti-tipper | YES |
D2
3
Image /page/3/Picture/0 description: The image shows a black and white drawing of a figure standing on top of a platform. The figure appears to be wearing a robe or gown, and it has a small head with a hat. The platform has a rectangular shape with some geometric designs on the front. The drawing is simple and lacks detail, but it is clear and easy to understand.
.
.
Shanghai Phoenix Medical Equipment CO., LTD.
NO.188 Zhongfa Road.Zhujing Industrial Park.Jinshan District Shanghai China Tel: 086-021-67221555 - Fax:086-021-67221999 E-mail:ph(@phoenixmed.com.cn
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12. 2013
Shanghai Phoenix Medical Equipment Co., Ltd. Ke-Min Jen. Official Correspondent No. 188 Zhonfga Road Zhujing Industrial Park Jinshan District, Shanghai China 201500
Re: K130848
Trade/Device Name: Shanghai Phoenix Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 15, 2013 Received: September 24, 2013
Dear Ke-Min Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your Section 910(x) premained 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 encrosule) to tegary manatinent date of the Medical Device American Drug commerce prior to May 20, 1976, the chaonnene 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. You may, interefore, market the active, subject to and growinements for annual registration, listing of I he general controls provisions of the Hordan 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), If your device is classified (SCC above) into entire) major regulations affecting your device can be If may be subject to additional controls. Bittlems, 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 Please be advised fill I DA 3 issuation of a succession of the requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decertifications administered by other Federal agencies. You must or any Federal statutes and regulations administer or of career in the firsting (21
5
Page 2 - Ke-Min Jen
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/MedicalDevices/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -S
for
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K130848
Device Name: Shanghai Phoenix Mechanical Wheelchair
Indications For Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 1 of ____________________________________________________________________________________________________________________________________________________________________