VALENTINE STEEL WHEELCHAIR

• K Number: K130017
• Device Name: VALENTINE STEEL WHEELCHAIR
• Manufacturer: VALENTINE INTL. LTD.
• Date Cleared: 2014-05-28 ( 511 days)
• Product Code: IOR
• Regulation Number: 890.3850

Intended Use

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Device Description

The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test.

Predicate Devices

K112816

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard manual wheelchair with no mention of AI, ML, or any computational processing beyond basic mechanical function.

Therapeutic

No
Explanation: A therapeutic device is used for treating or alleviating disease or injury. This device, a wheelchair, provides mobility support but does not directly treat or alleviate a medical condition.

Diagnostic

No
Explanation: The device description states its purpose is to provide mobility to persons restricted to a sitting position, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical wheelchair with a base, wheels, and seat, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a sitting position. This is a physical function, not a diagnostic test performed on samples from the human body.
• Device Description: The description details a wheelchair, a mechanical device for mobility. There is no mention of reagents, samples, or any components typically associated with in vitro diagnostics.
• 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.)
  • Detecting or measuring substances in those samples
  • Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.

Therefore, the Valentine Steel Wheelchair, model: 1000 is a medical device for mobility, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Product codes (comma separated list FDA assigned to the subject device)

IOR

Device Description

The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test.

The maximum weight bearing capacity of the device is 250 lbs/113.5 kgs. The following surfaces are recommended not to operate on:

• Sand surface
• Wet or icy surface .
• Road maintenance hole metal cover ●
• Multiple steps.
• Escalators. ( Use the elevator.)
• Steep incline over 10 degrees.
• . Ground clearance over 60 mm / 2.3"
• Curb climbing ability over 20 mm / 0.8"

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)

Valentine Steel Wheelchair, model: 1000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

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.

K112816

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

Regulation Number and Section

§ 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).

Summary

0

valentine international Lu.

詠 立 實 業有限公司 E-mail : [e-mail] http : // www.valentine-dynalife.com

Tel:[phone] Fax:[phone]

" 510(k) SUMMARY"

MAY 2 8 2014

K130017

Submitter's Name: Valentine International Ltd.

8F, No. 149, Sec. 2, Ta Tung Rd., Hsichih District, New Taipei City, 221, Taiwan, R.O.C.

Date of summary prepared: December 31, 2013

Device Name:

Valentine Steel Wheelchair, model: 1000 Proprietary Name: Mechanical Wheelchair Common or Usual Name: Classification Name: Mechanical Wheelchair, Class 1, 21 CFR 890.3850

510K contact person for all correspondence

Dr. Jen. Ke-Min Tel: [phone] Fax: [phone] Email: [e-mail]

Indications for Use:

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Description of the device:

The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test.

The maximum weight bearing capacity of the device is 250 lbs/113.5 kgs. The following surfaces are recommended not to operate on:

• Sand surface
• Wet or icy surface .
• Road maintenance hole metal cover ●
• Multiple steps.
• Escalators. ( Use the elevator.)
• Steep incline over 10 degrees.
• . Ground clearance over 60 mm / 2.3"
• Curb climbing ability over 20 mm / 0.8"

1

立實業有限公司 ફંગ્રે E-mail : [e-mail] http : // www.valentine-dynalife.com

Legally marketed device for substantial equivalence comparison:

Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816)

Performance Testing:

Valentine Steel Wheelchair, model: 1000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Technological Characteristics Summary:

To ensure the safety and effectiveness of the following ISO standards were complied with:

• ISO7176-1:1999, Wheelchairs - Part 1: Determination of Static Stability.
• ISO7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes. .
• ISO7176-5: 2008, Wheelchairs Part 5: Determination of overall dimensions, ● mass and maneuvering space.
• ISO7176-7: 1998, Wheelchairs Part 7: Measurement of seating and wheel . dimensions.
• . ISO7176-8: 1998, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths.
• . ISO7176-11:2012, Wheelchairs - Part 11: Test dummies.
• ISO7176-13:1989, Wheelchairs Part 13: Determination of coefficient of friction ● of test surfaces.
• ISO7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, . documentation and labelling.
• ISO7176-16:2012, Wheelchairs Part 16: Resistance to ignition of upholstered ● parts. Requirements and test methods.

Discussion of Clinical Testing Performed:

NA

2

valentine · international · Ltd. 詠 立 實 業 有 限 公 司 E-mail : [e-mail] http : // www.valentine-dynalife.com

Tel:[phone] Fax:[phone]

Comparison Table between the subject device and predicate device:
ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
BRAND NAME	Zhenjiang Assure	Valentine
MANUFACTURER	Zhenjiang Assure Medical
Equipment Co., Ltd.	Valentine
International Ltd.
MODEL NO	Mechanical Wheelchair, A227	Steel Wheelchair,
model 1000
510K NO	K112816	K130017
INTENDED USE	The device is intended for medical
purposes to provide mobility to
persons restricted to a sitting
position.	Same
OPERATING	Indoor / outdoor wheelchair	Same
TECHNOLOGICAL
CHARACTERISTICS	According to ISO
7176-1/-3/-5/-7/-8/-11/-13/-15/-16
series standards	Same
FRAME
Seat width
Cross brace
Seat height
Backrest height
Reclining backrest
Seat sling
Frame colors	18"
YES
20"
un-adjustable
fixed
padded nylon
Blue	Same
ARMREST
Arm pad
Flip back
Height-adjustable	Padded
YES, detachable
Pre-installed armrests	Same
HANGERS
Swing-away
Elevating leg rest
Articulating leg rest
Footplate style
Heel loop
Footrest angle	YES
YES
YES
Padded
No
10~150	Same
REAR AXLE
Offset axle
Quick-release axle	YES
YES	Same

D3

3

valentine international Luc.

詠 立實業有限公司

E-mail : [e-mail] http : // www.valentine-dynalife.com

Tel:[phone] Fax:[phone]

ITEMS	PREDICATE DEVICE	SUBJECT DEVICE
REAR WHEEL
Size
Tire type
Handrim material	24"
PU solid material
Steel composite	Same
CASTERS
Size
Tire type	8"
PU solid material	Same
WHEEL LOCK	Pull-to-Lock	Same
WEIGHT CAPACITY	250 lbs/113.5 kgs	Same
WEIGHT OF CHAIR	40 lbs / 18.2 kgs	Same
WARRANTY	12 months for the main parts
(The chair side frames are
guaranteed for 5 years from the date
of purchase. )	Same
ACCESSORIES
Anti-tipper
Rear stepper
Fold down push
handle
Safety belt	YES
YES
YES
Optional	NO
YES
YES
Optional

※ Actually, the subject device is identical to and transferred from the predicate device.

Substantial equivalence comparison discussion:

Actually, the subject device is identical to and transferred from the predicate device. From the above comparison table the intended uses between the subject device: Valentine Steel Wheelchair, model: 1000 and the predicate device: Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816) are the same. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the requirements for flame retardant. The differences in the overall appearance do not raise any safety or effectiveness aspect. Thus the subject device is substantially equivalent to the predicate device.

D4

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2014

Valentine International, Limited Dr. Jen. Ke-Min 8F, No. 149, Sec. 2, Ta Tung Rd., Hsichih District - New Taipei City 221 Taiwan. R.O.C.

Re: K130017

Trade/Device Name: Valentine Steel Wheelchair, model: 1000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 6, 2014 Received: April 15, 2014

Dear Dr. Jen, Ke-Min:

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 or any I 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

5

Page 2 - Dr. Jen. Ke-Min

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K130017

Device Name

Valentine Steel Wheelchair, model: 1000

Indications for Use (Describe)

The device is intended for medical purpose to provide mobility to persons restricted to a sitting 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

ം Date: 2014.05.28 17:26:40

-04'00'

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