California Comfort Four Wheel
by Jubilee Scooters, Inc. 510(k)
Active
510(k) K895384
Overview
The California Comfort Four Wheel is a Special Grade Wheelchair, classified as a Class II medical device under FDA regulations. It is designed as a mobility aid for individuals requiring assistance in ambulation, featuring a four-wheel configuration for enhanced stability and maneuverability in various environments.
This device is supplied as a reusable mobility scooter intended for use in home, community, and clinical settings. It is not sterile and requires proper maintenance and cleaning as per manufacturer guidelines. The California Comfort Four Wheel holds an FDA 510(k) clearance (K895384) under the Physical Medicine advisory committee, with a decision date of September 18, 1989. No third-party review or MRI safety information is specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895384 | Date18 Sep 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3880
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Questions
Is the California Comfort Four Wheel designed for use in clinical settings like hospitals or only for home and community environments?
The California Comfort Four Wheel is explicitly designed for use in home, community, and clinical settings, making it suitable for hospitals, rehabilitation centers, and other healthcare environments where mobility assistance is required. Its four-wheel configuration enhances stability, which is particularly useful in clinical spaces where maneuverability and safety are critical.
How is the California Comfort Four Wheel supplied, and what maintenance does it require?
The California Comfort Four Wheel is supplied as a reusable mobility scooter, meaning it is intended for long-term use with proper care. Since it is not sterile, it requires regular cleaning and maintenance as outlined by the manufacturer to ensure safe and effective operation. Routine upkeep will extend its lifespan and functionality.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?
The California Comfort Four Wheel received FDA clearance through a Traditional 510(k) pathway under the Physical Medicine advisory committee, with a clearance number of K895384. The decision was dated September 18, 1989, and classified as Substantially Equivalent (SESE), meaning the FDA determined it is as safe and effective as a legally marketed predicate device. This pathway ensures compliance with FDA standards for Class II medical devices.
Are there different sizes or models available for the California Comfort Four Wheel, and how would I determine the right fit for a user?
While the provided data does not specify exact sizes or model variations, the California Comfort Four Wheel is categorized as a Special Grade Wheelchair, implying it is designed to accommodate a range of user needs with adjustable features. For precise sizing, consulting the manufacturer’s guidelines or a healthcare professional would be necessary to ensure proper fit, weight capacity, and comfort for the intended user.