(80 days)
Not Found
Not Found
No
The summary describes a manual wheelchair with no mention of AI or ML capabilities.
No.
The device is described as a "mobility unit" providing transport for invalids. It does not treat or cure a disease or condition, but rather aids in daily living by providing mobility assistance.
No
Explanation: The device is described as a mobility unit intended to provide transport for invalids, not to diagnose medical conditions.
No
The device description clearly describes a physical mobility unit (wheelchair) with hardware components like armrests and footrests, not a software-only device.
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 to individuals who cannot walk. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the physical design and features of a mobility unit (like a wheelchair). It doesn't 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:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Diagnosing diseases or conditions
- Using reagents or laboratory procedures
The device described is clearly a mobility aid, likely a wheelchair, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices.
The models to be offered are of different sizes allowing for user preferance because of physical needs. Options for users include removeable armrests & detachable footrests to accomodate user requirements.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled.
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.
Not Found
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
§ 890.3850 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 logo for "HEARTWAY". The logo consists of the word "HEARTWAY" in bold, sans-serif font, with a stylized graphic above it. The graphic is composed of several horizontal lines that are arranged in a semi-circular or arched shape, resembling a series of stacked, curved bars. The overall design is simple and bold, with a focus on the text and the geometric shape above it.
HEARTWAY MEDICAL PRODUCTS CO
NO. 4, ROAD 5, TAICHUNG INDUSTRIAL PARK, HUNG. TAIWAN FI. O. C 80357 (Sales Den
DEC - 4 1997
Internet: http://www.webtree.net.tw/heartway/ E-mail: heartway@webtree.net.tw
Office of Device Evaluation 510(k) Document Mail Center (HFZ-401) Food & Drug Administration 1390 Piccard Drive Rockville, Maryland 20850
Dear Sir or Madam,
In accordance with the requirements of section 510(k) of the Federal Food and Drug Cosmetic Act we hereby request to register for commercial distribution for the following device.
| Device Name ------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| Common Name ------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Heartway Models--------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Proprietary Name ------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Established Registration No. ------------------------------------------903564 | |
| FDA Classification ----------------------------------------------------------------------------------------------------------------------------------------------------------- |
Summary
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices.
The wheelchairs listed above are substantially equivalent to many products being Marketed at this time. Wheelchairs of this type compare with the Invacare Tracer Plus Series (See Exhibit II) and the Everest & Jennings Traveler Series (see Exhibit III)
1
New Traveler
Image /page/1/Picture/1 description: The image shows a close-up of a wheelchair. The wheelchair is black and silver. The wheels are large and have a silver rim. The seat is not visible in the image.
TRAVELER QUALITY AND DURABILITY. . . Ever evolving to meet the needs of our customers, the "New" Traveler enhances its reputation as the rental wheelchair of choice. Now available with dual rear axle positioning for seat heights from 17-3/4" to 19-3/4", seat widths from 16" to 22" wide and a weight capacity of up to 300 pounds. The Traveler has earned its reputation for enduring the rigors of all types of use. . . designed to survive the journey.
- · Dual axle positioning ... seat heights between 17-3/4" and 19-3/4".
- · Front slide post design provides added rigidity and easy folding.
- · Reinforced top inner rail for extra strength.
- · Strong upholstery inner liner tested at 350 lbs. per inch, lasts twice as long as comparable models.
- · Low-maintenance, reinforced molded wheels with snap-on solid tires.
- · Desk length or full length arms available for easy transfer and access.
- · Superior E&J cam-action footrest design combined with quality manufacturing provide a snug fit and a true swing-away motion.
- · 300 lb. capacity on 20" and 22" wide models.
- · 2 year limited warranty on frame and crossbraces.
Image /page/1/Picture/12 description: The image shows the logo for Everest Jennings. The text "Everest Jennings" is in a bold, serif font. Below the company name is the tagline "Value through Innovation" in a smaller, italicized font. The logo is simple and professional.
2
TM
Image /page/2/Picture/1 description: The image is a black and white photograph of a metal structure. The structure appears to be a framework of some kind, with vertical and diagonal beams. The beams are connected by smaller pieces of metal. The image is dark and grainy, and the structure is not clearly defined.
DUAL AXLE BUSHINGS
Allows for easy seat conversion of seat heights from 17-3/4" to 19-3/4" through use of different wheels and caster combinations.
FEATURES
- ·Padded, double-embossed burgundy leatherette upholstery and padded armrests.
- •Durable 24" x 1" black molded wheel with snapon rubber tire.
- •8″ x 1″ black molded front casters.
- · Rugged cam-action swing-away detachable footrests or elevating legrests.
- •Durable aluminum footplate.
- ·Choice of 3 frame styles: std. fixed arm, Std/Hemi/Extra wide detachable arm and Std/Hemi recliners.
- · Available with a variety of optional arm styles.
All specifications subject to change without notice.
"New" Traveler™ Dimensions and Weights (inches and pounds)
| "New" Traveler
| Models | SEAT | ARMS | BACK | OVERALL | EXTENSIONS | WT. | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FOOTRESTS | LEGRESTS | LBS. | ||||||||||||
| Fixed Arm, Narrow Adult | 16 | 16 | $141/4$ | $101/8$ | $161/2$ | 30 | 36 | $221/2$ | $11$ | $161/2$ | 22 | 16 | 23 | 35 |
| Fixed Arm, Adult | 18 | 16 | $161/4$ | $101/8$ | $161/2$ | 30 | 36 | $241/2$ | $11$ | $161/2$ | 22 | 16 | 23 | 36 |
| Detachable Arm, | ||||||||||||||
| Narrow Adult, Hemi | 15 | 16 | $173/4$ | $93/4$ | $161/2$ | 30 | 36 | $241/4$ | $11$ | $161/2$ | 20 | 16 | 23 | 40 |
| Detachable Arm, Adult, Hemi | 18 | 16 | $173/4$ | $93/4$ | $161/2$ | 30 | 36 | $261/4$ | $11$ | $161/2$ | 20 | 16 | 23 | 41 |
| Detachable Arm, Narrow Adult | 16 | 16 | $193/4$ | $93/4$ | $161/2$ | 30 | 36 | $241/4$ | $11$ | $161/2$ | 22 | 16 | 23 | 40 |
| Detachable Arm, Adult | 18 | 16 | $193/4$ | $93/4$ | $161/2$ | 30 | 36 | $261/4$ | $11$ | $161/2$ | 22 | 16 | 23 | 41 |
| Detachable Arm | ||||||||||||||
| Narrow Adult Recliner | 16 | 17 | $193/4$ | $93/4$ | $233/8$ | 36 | $531/8$ | $241/4$ | 13 | $161/2$ | 22 | 15 | 21 | 55 |
| Detachable Arm, Adult Recliner | 18 | 17 | $193/4$ | $93/4$ | $233/8$ | 36 | $531/8$ | $261/4$ | 13 | $161/2$ | 22 | 15 | 21 | 55 |
| Detachable Arm | ||||||||||||||
| Adult-Wide (20") | 20 | 16 | $193/4$ | $93/4$ | $161/2$ | 30 | 36 | $281/4$ | $113/4$ | $161/2$ | 22 | 16 | 23 | 47 |
| Detachable Arm | ||||||||||||||
| Adult-Extra Wide (22") | 22 | 16 | $193/4$ | $93/4$ | $161/2$ | 30 | 36 | $301/4$ | $113/4$ | $161/2$ | 22 | 16 | 23 | 48 |
"Without front rigging. All dimensions are + or - 1/4"
NOTE: Everest & Jennings maintains the policy of continual product improvement, therefore we reserve the right to make changes without notice.
Everest & Jennings®
Value through Innovation
United States 4203 Earth City Exprswy St. Louis, MO 63045
203 Earth City Exprswy
St. Louis, MO 63045
For additional information call 1-800-235-4661 Canada LAK 218 For additional information call
1-905-669-2381
111 Snidecroft Road
Concord, Ontario,
Canada
Mexico Calle 3 No. 631 Zona Industrial Codigo Postal 44940 Guadalajara, Jalisco Mexico
For additional information call (011) 52-36-12-12-34
PN# 02003023 7/96 Printed in the USA
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Mr. Kenny Ho ·President Heartway Medical Products Company, Limited Number 4, Road 5, Taichung Industrial Park Taichung, Taiwan R.O.C.
K973491 Re: Mechanical Folding Wheelchair Requlatory Class: I Product Code: IOR Dated: October 27, 1997 -October 31, 1997 Received:
Dear Mr. Ho:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Kenny Ho
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Whitten, Ph.D.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page of
510(k) Number (if known): K973491
STANDARD FOLDING WHEELCHAIR Device Name:
Indications For Use:
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices.
The models to be offered are of different sizes allowing for user preferance because of physical needs. Options for users include removeable armrests & detachable footrests to accomodate user requirements.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
to see
Division of General Restorative Dev 510(k) Number
Prescription Use ._ (Per 21 CFR 801 109)
OR
Over-the-Counter Use. \
(Optional Format 1-2-96)