(108 days)
No
The description focuses on the mechanical and electrical components of a powered wheelchair and its control system, with no mention of AI or ML capabilities. The control system is explicitly stated to be a previously cleared device from 1997.
No
The device is described as a powered wheelchair intended to provide mobility, not to treat or cure a medical condition. While it aids mobility for individuals with limitations, its primary function is assistive, not therapeutic.
No
The device is a powered wheelchair designed to provide mobility, not to diagnose medical conditions.
No
The device description clearly outlines a physical, hardware-based powered wheelchair with components like motors, batteries, frame, wheels, and a joystick. While it mentions software within the motor controller, the device itself is a complex electromechanical system, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons with the capability of operating a powered wheelchair. This is a functional purpose related to physical assistance, not diagnostic testing.
- Device Description: The description details a powered wheelchair with features like seat lift and stand-up function. These are mechanical and electrical components for mobility and positioning, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, treatment, or prevention of disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This powered wheelchair does not fit that description.
N/A
Intended Use / Indications for Use
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
The Balder Finesse and Balder Junior powered wheelchairs are front-wheel driven power wheelchairs that have been designed and developed to be used in both indoor and outdoor environments. and to transport one (1) person at a time. The wheelchairs are outfitted with a seat lift, so that its user can reach objects on high shelves as well as slide their legs under the table when seated. The Balder Finesse and Balder Junior powered wheelchairs can also be purchased with a stand-up function option that allows the user to be placed in a stand-up position, thus allowing them to operate the wheelchair while standing. The Balder Finesse and Balder Junior powered wheelchairs operate using an electric, front-wheel drive motor that is driven by two (2) 12 Volt, 52 Amp dry cell batteries, and contains a D.C. permanent magnet type motor that uses graphite-copper brushes with integrated brakes (12/24V). The wheelchair frame is of welded steel construction and includes the rear castor wheels, front driving wheels with drive motor (i.e., motor, gear, brakes) and batteries. The motor controller, with joystick, can be mounted on either the left or right armrest depending on the user's needs. The motor controller, with joystick and software that is found in each wheelchair is manufactured by Dynamic Controls, a division of Invacare Corporation, and was previously cleared by the FDA on May 12, 1997 (see K970094).
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)
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission. In addition, the Balder Finesse and Balder Junior stand-up powered 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 Wheelchairs, and Motorized Three-Wheeled Vehicles.
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
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).
0
K072475
SECTION 5 – 510(k) SUMMARY
| Submission Correspondent: | Emergo Group, Inc. |
|---|---|
| Address: | 1705 S. Capital of Texas Hwy |
| Suite 500 | |
| Austin, TX 78746 | |
| Phone: | (512) 327-9997 |
| Fax: | (512) 327-9998 |
| Contact: | Mr. Ian Gordon |
| Submission Sponsor: | Etac Sverige AB |
| SE-165 | |
| 41 Kista, Sweden | |
| Tel: +46.8.633 47 00 | |
| Fax: +46.8.653 18 70 | |
| www.etac.com | |
| Date Prepared: | August 17, 2007 |
| Trade Name(s): | (1) Balder Finesse Powered Wheelchair |
| (2) Balder Junior Powered Wheelchair | |
| Common/Usual Name: | Powered Standup Wheelchair |
| Classification Name: | Wheelchair, Stand-up |
| Classification Number: | 890.3900 |
| Classification Panel: | Physical Medicine Devices |
| CDRH Product Code: | IPL |
| Regulatory Class: | II |
| Description: | The Balder Finesse and Balder Junior powered |
| wheelchairs are front-wheel driven power | |
| wheelchairs that have been designed and developed | |
| to be used in both indoor and outdoor environments. | |
| and to transport one (1) person at a time. The | |
| wheelchairs are outfitted with a seat lift, so that its | |
| user can reach objects on high shelves as well as | |
| slide their legs under the table when seated. The | |
| Balder Finesse and Balder Junior powered | |
| wheelchairs can also be purchased with a stand-up | |
| function option that allows the user to be placed in a | |
| stand-up position, thus allowing them to operate the | |
| wheelchair while standing. | |
| The Balder Finesse and Balder Junior powered | |
| wheelchairs operate using an electric, front-wheel | |
| drive motor that is driven by two (2) 12 Volt, 52 | |
| Amp dry cell batteries, and contains a D.C. | |
| permanent magnet type motor that uses graphite- | |
| copper brushes with integrated brakes (12/24V). | |
| The wheelchair frame is of welded steel | |
| construction and includes the rear castor wheels, | |
| front driving wheels with drive motor (i.e., motor, | |
| gear, brakes) and batteries. The motor controller, | |
| with joystick, can be mounted on either the left or | |
| right armrest depending on the user's needs. | |
| The motor controller, with joystick and software | |
| that is found in each wheelchair is manufactured by | |
| Dynamic Controls, a division of Invacare | |
| Corporation, and was previously cleared by the | |
| FDA on May 12, 1997 (see K970094). | |
| Intended Use: | The Balder Finesse and Balder Junior stand-up |
| powered wheelchairs by Etac are indoor/outdoor | |
| battery operated multifunctional wheelchairs. The | |
| intended use of these powered wheelchairs is to | |
| provide mobility to persons that have the capability | |
| of operating a powered wheelchair. | |
| Predicate Devices: | 1. LEVO Comfort II (K051387); Wheelchair (IPL) |
- DX Micro Computer Control for Power
Wheelchairs (K970094); Controller (ITI) |
| 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 |
1
:
2
| Performance Data: | 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 Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac and the predicate device, the LEVO Comfort II (K051387), do not raise any questions regarding their safety and effectiveness. | |
| The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac as designed are as safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referenced predicate device. | |
| The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission. In addition, the Balder Finesse and Balder Junior stand-up powered 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 Wheelchairs, and Motorized Three-Wheeled Vehicles. |
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEC 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Etac Sverige AB % Emergo Group, Inc. Mr. Ian Gordon Senior Vice President 1705 Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K072475
Trade/Device Name: Balder Finesse and Balder Junior Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: 89IPL Dated: November 29, 2007 Received: December 03, 2007
Dear Mr. Gordon:
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.
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.
4
Page 2 - Mr. Ian Gordon
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 (240) 276-0120. 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 Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Balder Finesse and Balder Junior
Indications for Use:
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
/`
(Division Sig-Off)
Division of General, Restorative, and Neurological I
510(k) Number