(283 days)
Not Found
No
The device description and performance studies focus on mechanical and structural aspects of a manual wheelchair, with no mention of AI/ML technologies or data-driven performance metrics.
No.
The device's stated intended use is to provide mobility to individuals limited to a seated position, which is a supportive function and not explicitly therapeutic in nature. While wheels may aid in mobility, this is not a therapeutic intervention.
No
Explanation: The device is a manual wheelchair, whose intended use is to provide mobility. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical, mechanical wheelchair with components like a frame, wheels, and casters, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Elevation Manual Wheelchair is a mobility aid designed to provide physical support and movement for individuals with limited mobility. It does not interact with or analyze biological specimens.
- Intended Use: The intended use is clearly stated as providing mobility to persons limited to a seated position. This is a mechanical function, not a diagnostic one.
- Device Description: The description details the physical components of a wheelchair, not equipment for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the wheelchair (stability, brakes, dimensions, strength, etc.), not on diagnostic accuracy or analytical performance.
Therefore, the Elevation Manual Wheelchair falls under the category of a medical device, but specifically a mobility aid, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.
The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.
The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
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
12 and up (adolescents and adults)
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)
The Elevation Manual Wheelchair has been tested to the following standards;
- ISO 7176-1:1999 Determination of Static Stability
- ISO 7176-3:2003 Determination of Effectiveness of Brakes
- ISO 7176-5:2008 Determination of Overall Dimensions, -Mass and Maneuvering Space
- -ISO 7176-7:1998 Determination of Seating and Wheel Dimensions
- -ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength
- -ISO 7176-13:1989 Determination of Coefficient of Friction of Test Surfaces
- ISO 7176-15:1996 Requirements for Information -Disclosure, Documentation and Labeling
- -ISO 7176-16:2012 Resistance to ignition of upholstered parts Requirements and test methods
- -ISO 7176-22:2000 Set up Procedures
The results of the non-clinical tests confirm that Elevation Manual Wheelchair is substantially equivalent to the predicate device.
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
§ 890.3850 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized image of an eagle or bird with three human profiles nested within its wing or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
PDG Product Design Group, Inc. c/o Edward Kroll, President Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, OH 44141
Re: K140023
Trade/Device Name: Elevation Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 16, 2014 Received: September 19, 2014
Dear Mr. Kroll:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at the following 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
for
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140023
Device Name Elevation Manual Wheelchair
Indications for Use (Describe)
The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated 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)
te: 2014.10.16 :09:22 -04'00'
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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4
Image /page/4/Picture/1 description: The image shows the logo for PDG Mobility. The logo is in two colors, orange and gray. The letters "PDG" are in orange, and the word "MOBILITY" is in gray and is located below the letters "PDG".
K140023 510(k) Premarket Notific
"510(k) SUMMARY"
AS REQUIRED BY SECTION 807.92(c)
(Modified October 06, 2014)
510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.
PDG Product Design Group, Inc. 103-318 East Kent Ave, South Vancouver, British Columbia Canada V5X4NC Phone: (604) 326-6644 Fax: (604) 323-9097 Email: tbrown@pdgmobility.com Web Site: www.pdgmobility.com
Contact Person:
Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant for PDG Product Design Group, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9801 Fax: (440) 546-9124
Date Prepared: December 26, 2013
Name of Device
- Trade Name: Elevation Manual Wheelchair
- Common Name: Manual Wheelchair ●
- Classification Name: Wheelchair, Mechanical Product Code IOR
Predicate Device
The Elevation Manual Wheelchair is substantially equivalent to the Icon Wheelchairs ICON Adult Manual Wheelchair (K110985)
5
K140023 510(k) Premarket Notific
Device Description:
The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.
The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.
The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
Device Function
Device function is dependent solely upon the wheelchair user. It does not function on its'own in any manner. The wheelchair user controls motion, speed and direction by propelling themselves using the hand rims located on the rear wheels.
Scientific Concepts
There are no complex scientific concepts related to the Elevation manual wheelchair. The Elevation is a simple, basic, manually operated mobility device.
Significant Physical and Performance Characteristics
Design:
The Elevation allows the user to adjust the seat height and back rest angle while the wheelchair is occupied. Seat height and back rest angle adjustment are achieved using gas springs which are mounted to the upper and lower frame assemblies. A tilt activator lever located on the right side of the lower frame is used to open and close the gas springs, thus activating and de-activating the adjustment features. It is to be used by adults and adolescents ages 12 and up with a maximum weight limit of 250lbs (114kg).
6
Image /page/6/Picture/1 description: The image shows the logo for PDG Mobility. The logo is orange and gray. The word "PDG" is in orange and the word "MOBILITY" is in gray and is located below the PDG letters.
K140023 510(k) Premarket Notific
Materials:
The Elevation frame is made from round, mechanical aluminum tubing that is welded together. The upholstery is made from foam polyurethane padding with nylon cover. These materials conform to FDA recognized standard ISO 7176-16:2012.
Physical Properties:
The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.
Intended Use/Indications for Use
The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
Predicate Device Comparison
The Elevation Manual Wheelchair is substantially equivalent to the Icon Wheelchairs ICON Adult Manual Wheelchair (K110985)
Performance Data: (Non-clinical Testing)
The Elevation Manual Wheelchair has been tested to the following standards;
- ISO 7176-1:1999 Determination of Static Stability -
- ISO 7176-3:2003 Determination of Effectiveness of Brakes -
- ISO 7176-5:2008 Determination of Overall Dimensions, -Mass and Maneuvering Space
- -ISO 7176-7:1998 Determination of Seating and Wheel Dimensions
- -ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength
- -ISO 7176-13:1989 Determination of Coefficient of Friction of Test Surfaces
- ISO 7176-15:1996 Requirements for Information -Disclosure, Documentation and Labeling
- -ISO 7176-16:2012 Resistance to ignition of upholstered parts Requirements and test methods
- -ISO 7176-22:2000 Set up Procedures
7
K140023 510(k) Premarket Notification
Conclusions of non-clinical tests
The results of the non-clinical tests confirm that Elevation Manual Wheelchair is substantially equivalent to the predicate device.
| ITEM/SPECIFICATION | ICON Adult Manual
Wheelchair | PDG PRODUCT DESIGN
GROUP ELEVATION | DISCUSSION |
|------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Accession Number | K110985 | K140023 | N/A |
| Clearance Date | May 3, 2011 | TBD | N/A |
| Indications for Use | Provide mobility to
persons limited to a
seated position | Same | No difference |
| DIMENSIONS, WEIGHT AND WEIGHT LIMITATION | | | |
| Front Seat to Floor Height | 12"-21" | 19 1/2"-20 1/2" | While the ICON has a wider range it
includes seat to floor heights which are
the same as the Elevation. |
| Caster Size | 3"-6" | 4"x1", 4"x 1.5" or 5"x 1.5" | The predicate offers 3" and 6" diameter
casters and the Elevation does not.
However, the Elevation caster sizes are
within the range of the predicate |
| Rear Wheel Diameters | 24"-25" | 24", 25" and 26" | The Elevation offers a 26" diameter
wheel and the ICON does not.
However, the remaining rear wheel
sizes are the same. This difference is
not significant in terms of safety or
effectiveness. The 26" rear wheel
would make the Elevation slightly
easier to self-propel. |
| Seat Width | 12"-19" | 14"-18" | The predicate offers a wider range than
the Elevation however, the Elevation
seat widths are within the range of the
predicate. |
| Seat Depth | 12"-20" | 14"-18" | The predicate offers a wider range than
the Elevation however, the Elevation
seat depths are within the range of the
predicate. |
| User Weight Limit | 250 lbs. | Same | No difference |
| ITEM/SPECIFICATION | ICON Adult Manual
Wheelchair | PDG PRODUCT DESIGN
GROUP ELEVATION | DISCUSSION |
| Chair Weight | 23 lbs. | 25 lbs. including wheels | The Elevation is slightly heavier than
the ICON. This is likely due to the gas
springs which are used for the seat and
back angle adjustment features of the
Elevation. The 2 pound difference is
not significant and has no effect on
safety or effectiveness. |
| MATERIALS | | | |
| Frame Material | Aluminum,
Titanium and
Composite | Aluminum | No difference since both are made from
aluminum |
| Upholstery | Polyurethane Foam
with Nylon Cover | Same | No Difference |
| Hand Rims | Aluminum Tubing | Same | No Difference |
| Ultra-Light Frame | Yes | Yes | No Difference |
| Back Angle Adjustment | Yes but must be done
without user seated
in the wheelchair. | Yes but can be adjusted
with the user in the
wheelchair. | Both devices have back angle
adjustment capability and the fixed
angles for the predicate are within the
range of the Elevation. Adjusting the
back angle with the chair being
occupied has no effect on safety. The
gas springs move the back rest angle
slowly. A failure of the gas spring while
fully extended would only return the
back rest to its' lower most position in
a slow manner. A failure in the fully
retracted position would only result in
the back rest feature not functioning.
In either case, patient safety is not
compromised. |
| Elevating Seat | No | Yes. Seat may be raised
and lowered while the
user is seated in the
wheelchair. | Adjusting the seat height with the user
in the chair has no effect on safety.
The gas springs raise and lower the
seat slowly. While a raised seat does
make the chair more susceptible to
tipping, the Elevation passed the ISO
7176- 1 Static Stability test with the
elevated seat in its' highest position.
Gas spring failure in the retracted
position would result only in the
elevating seat feature becoming
nonfunctional. Failure of one spring in
a fully extended position has no effect
as one spring has sufficient force to
ensure the seat is lowered in a slow
and non-abrupt manner. |
| Full Frame Design | Yes | No. Frame is in two pieces
mounted with gas springs | Two piece frame has no effect on
device safety. Frame strength is not
compromised. |
Elevation Manual Wheelchair Comparative Analysis
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Image /page/8/Picture/0 description: The image shows the logo for PDG Mobility. The logo is in two lines, with the top line showing the letters "pdg" in a stylized, connected font. The letters are orange. The bottom line shows the word "MOBILITY" in gray, block letters.