ELEVATION

K140023 · Pdg Product Design Group, Inc. · IOR · Oct 16, 2014 · Physical Medicine

Device Facts

• Record ID: K140023
• Device Name: ELEVATION
• Applicant: Pdg Product Design Group, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.

Device Story

Elevation Manual Wheelchair is an ultra-light, rigid-frame, manually operated mobility device for adolescents and adults. Device consists of lower frame assembly, seat sling, back rest, rear wheels with hand rims, and front swivel casters. User propels chair via hand rims; controls motion, speed, and direction. Features gas-spring-actuated seat height and backrest recline adjustment, operable by user while seated. Tilt activator lever on right side controls gas springs. Device used in various settings by patients; provides mobility and postural adjustment. Benefits include increased independence and ability to self-adjust seating position for comfort or function. No complex scientific concepts; purely mechanical operation.

Clinical Evidence

No clinical data. Bench testing only. Device tested to ISO 7176 standards: ISO 7176-1 (Static Stability), ISO 7176-3 (Brakes), ISO 7176-5 (Dimensions/Mass/Maneuvering), ISO 7176-7 (Seating/Wheel Dimensions), ISO 7176-8 (Static Impact/Fatigue Strength), ISO 7176-13 (Coefficient of Friction), ISO 7176-15 (Documentation/Labeling), ISO 7176-16 (Ignition Resistance), and ISO 7176-22 (Set up Procedures).

Technological Characteristics

Frame: welded round mechanical aluminum tubing. Upholstery: polyurethane foam padding with nylon cover (ISO 7176-16:2012 compliant). Actuation: gas springs for seat height and backrest recline. Operation: manual, user-propelled. Dimensions: seat width 14-18", seat depth 14-18". Weight limit: 250 lbs. No electronic components or software.

Indications for Use

Indicated for adolescents and adults ages 12 and up, limited to a seated position, requiring a manual wheelchair for mobility. Maximum weight limit 250 lbs (114 kg).

Regulatory Classification

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.

Predicate Devices

• ICON Adult Manual Wheelchair (K110985)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: [phone] Fax: [phone] Email: [e-mail] 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: [phone] Fax: [phone]

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<br>Wheelchair | PDG PRODUCT DESIGN<br>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<br>persons limited to a<br>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<br>includes seat to floor heights which are<br>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<br>casters and the Elevation does not.<br>However, the Elevation caster sizes are<br>within the range of the predicate |
| Rear Wheel Diameters | 24"-25" | 24", 25" and 26" | The Elevation offers a 26" diameter<br>wheel and the ICON does not.<br>However, the remaining rear wheel<br>sizes are the same. This difference is<br>not significant in terms of safety or<br>effectiveness. The 26" rear wheel<br>would make the Elevation slightly<br>easier to self-propel. |
| Seat Width | 12"-19" | 14"-18" | The predicate offers a wider range than<br>the Elevation however, the Elevation<br>seat widths are within the range of the<br>predicate. |
| Seat Depth | 12"-20" | 14"-18" | The predicate offers a wider range than<br>the Elevation however, the Elevation<br>seat depths are within the range of the<br>predicate. |
| User Weight Limit | 250 lbs. | Same | No difference |
| ITEM/SPECIFICATION | ICON Adult Manual<br>Wheelchair | PDG PRODUCT DESIGN<br>GROUP ELEVATION | DISCUSSION |
| Chair Weight | 23 lbs. | 25 lbs. including wheels | The Elevation is slightly heavier than<br>the ICON. This is likely due to the gas<br>springs which are used for the seat and<br>back angle adjustment features of the<br>Elevation. The 2 pound difference is<br>not significant and has no effect on<br>safety or effectiveness. |
| MATERIALS | | | |
| Frame Material | Aluminum,<br>Titanium and<br>Composite | Aluminum | No difference since both are made from<br>aluminum |
| Upholstery | Polyurethane Foam<br>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<br>without user seated<br>in the wheelchair. | Yes but can be adjusted<br>with the user in the<br>wheelchair. | Both devices have back angle<br>adjustment capability and the fixed<br>angles for the predicate are within the<br>range of the Elevation. Adjusting the<br>back angle with the chair being<br>occupied has no effect on safety. The<br>gas springs move the back rest angle<br>slowly. A failure of the gas spring while<br>fully extended would only return the<br>back rest to its' lower most position in<br>a slow manner. A failure in the fully<br>retracted position would only result in<br>the back rest feature not functioning.<br>In either case, patient safety is not<br>compromised. |
| Elevating Seat | No | Yes. Seat may be raised<br>and lowered while the<br>user is seated in the<br>wheelchair. | Adjusting the seat height with the user<br>in the chair has no effect on safety.<br>The gas springs raise and lower the<br>seat slowly. While a raised seat does<br>make the chair more susceptible to<br>tipping, the Elevation passed the ISO<br>7176- 1 Static Stability test with the<br>elevated seat in its' highest position.<br>Gas spring failure in the retracted<br>position would result only in the<br>elevating seat feature becoming<br>nonfunctional. Failure of one spring in<br>a fully extended position has no effect<br>as one spring has sufficient force to<br>ensure the seat is lowered in a slow<br>and non-abrupt manner. |
| Full Frame Design | Yes | No. Frame is in two pieces<br>mounted with gas springs | Two piece frame has no effect on<br>device safety. Frame strength is not<br>compromised. |

## Elevation Manual Wheelchair Comparative Analysis

{8}------------------------------------------------

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.

## K140023 510(k) Premarket Notification

### Response to RTA Decision