Skippi Powered Wheelchair for Children
510(k) K070318
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070318 | Date11 May 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Skippi Powered Wheelchair for Children is a powered mobility device designed for pediatric use, classified as a Powered Wheelchair. It is engineered to provide independent mobility for children with limited walking ability or severe mobility impairments, enabling them to navigate their environment with enhanced freedom and exploration. Its design prioritises compactness and manoeuvrability to accommodate growing children while ensuring ease of use in various settings.
This device is intended for clinical use in physical medicine settings and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. Supplied as a reusable mobility solution, the Skippi is adjustable to accommodate developmental growth and requires proper maintenance per manufacturer guidelines. No specific sterility or MRI safety information is provided in the regulatory data, and its use is restricted to non-vehicle transportation applications as of the current submission.
From the manufacturer
The Ottobock Skippi lets your child move about independently and explore their environment. The power wheelchair grows along with the child and can be individually adjusted. The Skippi power wheelchair gives children with even severe disabilities a measure of independence. Its key features are manoeuvrability and ease of transportation.
Other devices from Otto Bock HealthCare LP
Questions
AI-generated answers, 20 Sep 2026
What age group is the Skippi Powered Wheelchair designed for and how does it accommodate growth over time?
The Skippi Powered Wheelchair is specifically designed for pediatric use, intended to provide mobility solutions for children with limited walking ability or severe mobility impairments. It is adjustable to accommodate developmental growth, ensuring it can be adapted as the child grows, though it is not a single-use device and is meant to be reused with proper maintenance per manufacturer guidelines.
Is the Skippi Powered Wheelchair suitable for use in an MRI environment, and if not, why?
The regulatory data for the Skippi Powered Wheelchair does not provide any specific information regarding MRI safety. Therefore, it cannot be assumed to be MRI-compatible, and caution should be exercised when considering its use in an MRI environment. Always verify compatibility with MRI equipment and protocols before use.
How is the Skippi Powered Wheelchair supplied, and what type of maintenance does it require?
The Skippi Powered Wheelchair is supplied as a reusable mobility solution. It requires proper maintenance as outlined by the manufacturer to ensure safe and effective operation. Since it is designed for pediatric use and adjustability, regular upkeep is essential to accommodate growth and to maintain functionality over time.
What regulatory pathway was followed for FDA clearance of the Skippi Powered Wheelchair, and what does this mean for its use?
The Skippi Powered Wheelchair received FDA clearance under the Traditional 510(k) pathway, classified as a Class II medical device. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets the necessary safety and performance standards for its intended use as a powered mobility device in pediatric settings. The clearance does not imply any specific clinical indication but confirms regulatory compliance for non-vehicle transportation applications.
Are there multiple models or sizes available for the Skippi Powered Wheelchair, and how would one determine the appropriate fit for a child?
The Skippi Powered Wheelchair is available in multiple configurations, as indicated by the extensive list of FEI numbers in the regulatory data, which likely correspond to different models or customizable features. The appropriate fit for a child would depend on their specific mobility needs, developmental stage, and physical measurements. A certified healthcare professional or mobility specialist should assess the child’s requirements and adjust the wheelchair accordingly to ensure optimal performance and safety.