(124 days)
Not Found
No
The description focuses on mechanical and electronic components (controller, brakes, motor) and standard performance testing, with no mention of AI or ML.
No.
The device is a power wheelchair designed for mobility and sports activities, not for treating or alleviating a disease or condition. While it assists individuals with certain conditions, its primary function is assistive mobility, not therapy.
No
Explanation: The device is described as a powered standup wheelchair intended for mobility and sports activities, not for diagnosing medical conditions.
No
The device description explicitly states it is a "front wheel drive powered standup wheelchair" with physical components like a "U" frame, controller, brakes, and motor, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a powered standup wheelchair designed to assist individuals with mobility limitations. Its purpose is to enable movement and participation in activities, not to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, analysis of biological materials, or providing diagnostic information.
Therefore, based on the provided information, the ParaGolfer Standup Wheelchair is a mobility aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ParaGoIfer Standup Powered Wheelchair is indicated for:
- Any individual who needs a power wheelchair and can not stand up on their own such as people with Paraplegia, Spina Bifida, Cerebral Paresis, Multiple Sclerosis, Muscular Dystrophy, and Polio.
- Any individual to take part in sports activities requiring an upright position.
Product codes (comma separated list FDA assigned to the subject device)
IPL
Device Description
The ParaGolfer Standup Wheelchair is a front wheel drive powered standup wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare.
The ParaGolfer Standup Wheelchair has a "U" frame, controlled by a Curtis Instruments Controller, electronic regenerative disc brakes and Micro Motor.
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 ParaGolfer was tested by TÜV Product Service to the following standards:
- EN 12184 .
- ISO 7176 Series, including 7176-20 .
- ANSI/RESNA WC Vol. 2 Section 21 Amendments 1998 for EMC .
with the conclusion that "the test sample fulfills the requirements."
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
Image /page/0/Picture/0 description: The image is a black and white logo for "PARAGOLFER by ParaBaseTec". The logo features a circle with the text "PARAGOLFER" at the top and "by ParaBaseTec" at the bottom. Inside the circle is a diamond shape with the letters "PB" stacked on top of each other. There are two wings on either side of the diamond shape.
Ko60936
ParaBaseTec GmbH · Hauptstrasse 3 c · 37434 Bodensee
510(k) Summary
AUG - 7 2006
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| 1. Submitter's Name: | ParaBaseTec, GmbH |
|---|---|
| 2. Address: | Haupstrasse 3C |
| Bodensee, Germany | |
| 3. Telephone: | 49-5507-979-9108 |
| 4. Contact Person: | Anthony Netto |
| 5. Date Prepared: | March 28, 2006 |
| 6. Registration Number: | In Process |
B. Device
| 1. | Name: | ParaGolfer |
|---|---|---|
| 2. | Trade Name: | ParaGolfer |
| 3. | Common Name: | Standup Wheelchair |
| 4. | Classification Name: | Wheelchair, Standup |
| 5. | Product Code: | IPL |
| 6. | Class: | II |
| 7. | Regulation Number: | 890.3900 |
ParaBaseTec Inc - Story brick office building - 2 Carlson Parkway, Suite 100 - 3041 - 840 - 3741 E Leland St. Mesa, Az 85215 lek office Ballaing - E - 52 - Toll Free (800) 328-40 58 - Voicemail (800) 905-27 50 lone 1 1 (400) 191 -5-149 63 - Fax1 (763) 519-61 53 · Fax2 (480) 832-01 78 www.parabasetec.com · info@parabasetec.com Bank One 2020 E Mckellips Mesa Az 85213 · Routing nr. 122 100 024 · Account nr. 693 786 899 CEO: Steven Wayne Winter
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Image /page/1/Picture/0 description: The image is a logo with the word "PARAGOLFER" in a circular shape at the top. There is a black diamond shape in the center with the letters "PB" in white. There are two wings on either side of the diamond shape. The words "by paraBaseTec" are at the bottom of the logo.
ParaBaseTec GmbH · Hauptstrasse 3 c · 37434 Bodense
C. Identification of Legally Marketed Devices
| 1. Name: | comfort II |
|---|---|
| 2. K Number: | K051387 |
| 3. Date Cleared: | June 10 2005 |
D. Description of the Device
The ParaGolfer Standup Wheelchair is a front wheel drive powered standup wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare.
The ParaGolfer Standup Wheelchair has a "U" frame, controlled by a Curtis Instruments Controller, electronic regenerative disc brakes and Micro Motor.
E. Intended Use Statement
The ParaGoIfer Standup Wheelchair is a front wheel drive powered standup wheelchair with an air-filled rear wheel for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments MC-2 Control System that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheel. It features a servo-steering with release mechanism. The ParaGolfer has an integrated stand-up function. When actuating the standup function via the control console, a motorized lifting device moves the seat of the ParaGolfer from a horizontal to vertical position. At the same time the angles on the backrest and footrest adapt in such a way that the user is brought to an upright posture.
F. Technological Characteristics Summary
The ParaGolfer Wheelchair is substantially equivalent to the LEVO AG comfort II Wheelchair, cleared on June 10, 2005 as K051387.
Each wheelchair is a standup, powered wheelchair for the active user, with a rigid frame and similar characteristics.
ParaBaseTec Inc · Story brick office building · 2 Carlson Parkway, Suite 100 · Plymouth, MN 55447-4407 · 3741 E Leland St. Mesa, Az 85215 Phone + 1 (480) 797-52 59 · Toll Free (800) 328-40 58 · Voicemail (800) 905-27 50 Toll Free Fax (800) 655-49 63 · Fax1 (763) 519-61 53 · Fax2 (480) 832-01 78 www.parabasetec.com · info@parabasetec.com Bank One 2020 E Mckellips Mesa Az 85213 · Routing nr. 122 100 024 · Account nr. 693 786 899 CEO: Steven Wayne Winter
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E. Contact
ﻣﻌ ﻣ
Contact Person: Anthony Netto
Telephone: 49-5507-979-9108
Facsimile: 49-55-7-979-144
म् . FDA Registration
Registration No.: In Process Owner/Operator No.: In Process
G. Name/Address of Assembler
Assembler Company: OTTO BOCK HealthCare GmbH
Street Address: Lindenstrasse 13
City: Konigsee
Country: Germany
Postal Code: D-07426
H. Contact
Contact Person: Tom Wessel
Telephone: 763-489-5134
Facsimile: 763-519-9017
I. FDA Registration
Registration Number: 9681725 Owner/Operator Number: 8010097
3
Image /page/3/Picture/0 description: The image is a black and white logo for "PARAGOLFER by ParaBaseTec". The logo features a circle with the text "PARAGOLFER" at the top and "by ParaBaseTec" at the bottom. Inside the circle, there is a diamond shape with the letters "PB" stacked on top of each other. There are wing-like shapes extending from the diamond to the left and right.
ParaBaseTec GmbH - Hauptstrasse 3 c - 37434 Bodensee
The ParaGolfer was tested by TÜV Product Service to the following standards:
- EN 12184 .
- ISO 7176 Series, including 7176-20 .
- ANSI/RESNA WC Vol. 2 Section 21 Amendments 1998 for EMC .
with the conclusion that "the test sample fulfills the requirements."
ParaBaseTec Inc · Story brick office building · 2 Carlson Parkway, Suite 100 · Plymouth, MN 55447 · 3741 E Leland St. Mesa, A2 85215 Phone + 1 (480) 797-52 59 · Toll Free (800) 328-40 58 · Voicemail (800) 905-27 50 Toll Free Fax (800) 655-49 63 · Fax1 (763) 519-61 53 · Fax2 (480) 832-01 78 www.parabasetec.com · info@parabasetec.com Bank One 2020 E Mckellips Mesa Az 85213 · Routing nr. 122 100 024 · Account nr. 693 786 899 CEO: Steven Wayne Winter
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird design with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2006
ParaBaseTec. GmbH % W F Jackson Associates, Ltd. Mr. William Jackson Regulatory Consultant 2247 Jennifer Lane St. Paul. Minnesota 55109-2851
Re: K060936
Trade/Device Name: ParaGolfer Standup Powered Wheelchair Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: June 30, 2006 Received: July 6, 2006
Dear Mr. Kramer:
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.
5
Page 2 – Mr. William Jackson
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
Barbara Baechuo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: To be determined
Device Name: ParaGoIfer Standup Powered Wheelchair
Indications for Use:
- Any individual who needs a power wheelchair and can not stand up on their . own such as people with Paraplegia, Spina Bifida, Cerebral Paresis, Multiple Sclerosis, Muscular Dystrophy, and Polio.
- Any individual to take part in sports activities requiring an upright position. .
PRESCRIPTION USE
AND/OR
OVER-THE-COUNTER USE X (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qurbana Vneenut fa MKM
Division of General, Restorative, and Neurological Devices
510(k) Number K060936
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