PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT

K083231 · Panthera Production AB · IOR · Jan 26, 2009 · Physical Medicine

Device Facts

• Record ID: K083231
• Device Name: PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
• Applicant: Panthera Production AB
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair

Device Story

Panthera mechanical wheelchairs are manually operated, lightweight, performance-type mobility devices. Designed for indoor and outdoor use, they transport one person at a time. The device consists of a chrome-moly steel chassis, titanium alloy pushrims and footrests, and spoke-and-hub wheels with rubber tires. The seat and back are constructed from flame-retardant polyurethane-coated polyester fabric over a foam core. The device is operated by the user. It provides mobility to individuals capable of manual operation, facilitating daily navigation and independence. The product line includes five models (S2, U2, Bambino, Micro, BT) varying in dimensions, weight capacity, and adjustability.

Clinical Evidence

Bench testing only. The device demonstrated conformance to applicable ISO and EN standards and the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs.

Technological Characteristics

Manual wheelchair; chrome-moly steel chassis; titanium alloy pushrims and footrests; semi-solid polymer casters; flame-retardant polyurethane-coated polyester fabric seat/back; spoke-and-hub wheel design. No electronic components or software.

Indications for Use

Indicated for individuals capable of operating a manual wheelchair who require mobility assistance for indoor and outdoor environments.

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

• Invacare Top End Terminator Titanium wheelchair (K012167)
• Invacare Top End Terminator SS wheelchair (K990157)

Submission Summary (Full Text)

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KOr3231

# SECTION 5 - 510(k) SUMMARY

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| Submission Correspondent: | JAN 2 6 2009<br>Emergo Group, Inc |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1705 S Capital of Texas Hwy<br>Suite 500<br>Austin, TX 78746 |
| Phone | [phone] |
| Fax: | [phone] |
| Contact | Mr Stuart Goldman |
| Submission Sponsor: | Panthera Production AB<br>Gunnebogatan 26<br>163 53 Spånga<br>Sweden<br>Tel [phone]<br>Fax [phone]<br>E-Mail panthera@panthera se<br>www panthera se/index-eng html |
| Date Prepared: | September 23, 2008 |
| Trade Name(s): | Panthera Mechanical Wheelchairs<br>Models S2, U2, Bambino, Micro and BT |
| Common/Usual Name: | Mechanical Wheelchair |
| Classification Name: | Wheelchair, Mechanical |
| Classification Number: | 890 3850 |
| Classification Panel: | Physical Medicine Devices |
| CDRH Product Code: | IOR |
| Regulatory Class: | I |

## Section 5 1 - Device Description

Panthera mechanical wheelchairs are manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both

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ındoor and outdoor environments, and to transport one (1) person at a tıme These wheelchairs are made available by Panthera Production AB in five (5) different top-level models, with each model designed for a specific end-user application The five different models of chairs are the

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- � U2
- Bambıno .
- . Micro
- 0 BT

There are no basic differences in the general construction of each model wheelchair frame, or the materials and components used to make them The Chassis are made form chrome-molly steel, while their Pushrims and Footrests are made from a titanıum alloy Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design The seat cushion and back are made from flame retardant polyurethane coated polyester fabric, over a foam core The primary differences in the models of wheelchairs are in their dimensions, gross weights, weight carrying capacities, adjustability features, wheels, accessories and hardware options

### Section 5 2 - Intended Use

Panthera mechanical wheelchairs are manually operated muitifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheeichair

### Section 5 3 - Predicate Devices

5 3 1 - Invacare Top End Terminator Titanıum wheelchair (ref K012167) 5 3 2 - Invacare Top End Terminator SS wheelchair (ref K990157)

### Section 5 4 - Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device

As such, it has been shown in this 510(k) submission, that the differences between the Panthera mechanical wheelcharrs and the predicate devices, the Invacare Top End Terminator Titanıum wheelchair (ref K012167) and the

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Invacare Top End Terminator SS wheelchair (ref K990157) (K051387), do not raise any questions regarding their safety and effectiveness

Panthera mechanical wheelchairs as designed and manufactured are as safe and effective as the predicate devices and therefore are determined to be substantially equivalent to the referenced predicate devices

#### Section 5 5 - Performance Data

Panthera mechanical wheelchairs have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission In addition, Panthera mechanical wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchars, and Motorized Three-Wheeled Vehicles

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JAN 2 6 2009

Panthera Production AB % Emergo Group, Inc Mr Stuart R Goldman 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re K083231

Trade Name Panthera Mechanical Wheelchairs Models (S2, U2, Bambino, Micro and BT) Regulation Number 21 CFR 890 3850 Regulation Name Mechanical wheelchair Regulatory Class I Product Code IOR Dated September 30, 2008 Received November 5, 2008

#### Dear Mr Goldman

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, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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), 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

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#### Page 2 - Mr Stuart R Goldman

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Division of Postmarket Surveillance at [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Mark N Millerson

Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known)· ________________________________________

### Device Name

Panthera Mechanical Wheelchairs

Models (S2, U2, Bambino, Micro and BT)

### Indications for Use

Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

of

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) Division of General. Restorative, and Neurological ver

**510(k) Number**