(98 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components, standard testing, and predicate devices without mentioning any AI/ML capabilities or related data analysis.
No.
The primary purpose of the device is to provide mobility, not to treat or cure a medical condition.
No
The device description clearly states its purpose is to provide mobility. There is no mention of diagnosing any condition or disease.
No
The device description clearly outlines physical components like DC motors, a controller, a rigid frame, wheels, and optional hardware like a seat tilt mechanism and backrest adjustment. This indicates it is a physical medical device, not software-only.
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 physically challenged and limited to sitting positions." This describes a device used for physical support and mobility, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details mechanical and electrical components for propulsion and seating adjustments. There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Skippi wheelchair is a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Provide mobility to persons physically challenged and limited to sitting positions.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG.
The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires.
Options available to the end user are the following:
- Seat Tilt Mechanism, Electric or with Gas Compression Spring .
- Electric Backrest Angle Adjustment .
- Seating Shell Adapter .
- . Tray
- . Control for Attendant
- . Bumper Bar
- Single Panel Footrest .
- Colors (Yellow, Blue, or Red) .
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
The Skippi is for children or small people up to 110 pounds
Intended User / Care Setting
The Skippi is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments enAble 40 that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.
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 Skippi was tested by TÜV Product Service to the following standards:
- . EN 12184
- ISO 7176 -- Series .
- ANSI/RESNA WA 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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Otto Bock®
MAY 1 1 2007
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
B.
| 1. | Submitter's Name: | OTTO BOCK HealthCare LP |
|---|---|---|
| 2. | Address: | Two Carlson Parkway N., Suite 100 |
| Minneapolis, MN 55447-4467 | ||
| 3. | Telephone: | 763-253-5607 |
| 4. | Contact Person: | Shannon Tufvander |
| 5. | Date Prepared: | January 18, 2007 |
| 6. | Registration Number: | 2182293 |
| Device | ||
| 1. | Name: | Skippi Powered Wheelchair for Children |
| 2. | Trade Name: | Skippi Powered Wheelchair for Children |
| 3. | Common Name: | Powered wheelchair |
- Classification Name: Powered wheelchair
ITI 5. Product Code:
-
- Class: II
-
- Regulation Number: 890.3860
1
Otto Bock®
C. Identification of Legally Marketed Devices
| 1. Name: | A-200 |
|---|---|
| 2. K Number: | K052706 |
| 3. Date Cleared: | December 27, 2005 |
D. Description of the Device
The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG.
The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires.
Options available to the end user are the following:
- Seat Tilt Mechanism, Electric or with Gas Compression Spring .
- Electric Backrest Angle Adjustment .
- Seating Shell Adapter .
- . Tray
- . Control for Attendant
- . Bumper Bar
- Single Panel Footrest .
- Colors (Yellow, Blue, or Red) .
E. Intended Use Statement
The Skippi is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments enAble 40 that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.
F. Technological Characteristics Summary
2
Otto Bock®
QUALITY FOR LIF
The Skippi Wheelchair is substantially equivalent to the OTTO BOCK A-200 Wheelchair, cleared on December 27, 2005 as K052706.
Each wheelchair is a powered wheelchair for the active user, with a rigid frame and similar characteristics. The Skippi is for children or small people up to 110 pounds, whereas the A-200 is for anyone up to 200 pounds.
The Skippi was tested by TÜV Product Service to the following standards:
- . EN 12184
- ISO 7176 -- Series .
- ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC .
with the conclusion that "the test sample fulfills the requirements."
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2007
OTTO BOCK HealthCare, LP % Mr. William Jackson Regulatory Consultant 2247 Jennifer Lane St. Paul, Minnesota 55109-2851
Re: K070318
Trade/Device Name: Skippi Powered Wheelchair for Children Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 18, 2007 Received: April 27, 2007
Dear Mr. Jackson:
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. 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 vor
for
Mark N. Melkerson
Romm 5/16/07
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): To be determined
Device Name: Skippi Powered Wheelchair for Children
Indications for Use:
- Provide mobility to persons physically challenged and limited to sitting positions. �
Prescription Use (Part 21 CFR 801 Subpart D) 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 Deyice uation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070318
Page 1 of 1