Drake & Drake/200 Dl
by Am Scooters 510(k)
Active
510(k) K921467
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921467 | Date29 Apr 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- INI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Drake & Drake 200 DL is a motorized three-wheeled vehicle designed for mobility assistance. Classified as a Class II device under FDA regulation 890.3800, it falls under the category of motorized wheelchairs or mobility scooters, intended to provide independent transportation for individuals with limited mobility.
This device is supplied as a reusable, non-sterile product and is intended for use in home, clinical, or community settings. It is regulated under the FDA’s 510(k) clearance (K921467) with a decision date of April 29, 1992, and is classified under the Physical Medicine specialty. No MRI safety information or specific storage requirements are noted in the regulatory data.
Other devices from Am Scooters
Questions
AI-generated answers, 1 Oct 2026
What is the Drake & Drake 200 DL designed for?
The Drake & Drake 200 DL is a motorized three-wheeled vehicle designed specifically for mobility assistance. It provides independent transportation for individuals with limited mobility, allowing them to move freely in home, clinical, or community environments. Its classification as a Class II device under FDA regulation 890.3800 confirms its intended use for enhancing mobility and accessibility.
Is the Drake & Drake 200 DL reusable or single-use?
The Drake & Drake 200 DL is supplied as a reusable product. Unlike single-use devices, it is intended for repeated use by individuals or across multiple users in settings such as homes, clinics, or public spaces. This design aligns with its classification as a mobility aid rather than a sterile medical instrument.
What are the key specifications or models associated with this device?
The Drake & Drake 200 DL is associated with multiple registration numbers (e.g., 3033905189, 3012604975) and FEI numbers (e.g., 3037000105, 1000221992) in the FDA database. These identifiers track variations or configurations of the device but do not imply different clinical functions. The device is regulated under product code INI and falls under the Physical Medicine specialty.
Are there any special storage requirements for the Drake & Drake 200 DL?
The regulatory data for the Drake & Drake 200 DL does not specify any special storage requirements beyond standard practices for mobility scooters. Since it is non-sterile and reusable, it should be stored in a clean, dry environment to prevent damage or contamination. Users should follow manufacturer guidelines for maintenance and upkeep to ensure safe and reliable operation.
What regulatory pathway was followed for the Drake & Drake 200 DL?
The Drake & Drake 200 DL was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process. It was determined to be substantially equivalent to a predicate device, earning clearance with the decision code SESE (Substantially Equivalent) on April 29, 1992. This pathway is common for Class II devices like mobility scooters, where the FDA evaluates safety and effectiveness against existing, legally marketed alternatives.