Legend Sc 300
510(k) K926295
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK926295 | Date28 Mar 1994 | 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- Withdrawn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
- INI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SN
Overview
AI-generated summary, 27 Sep 2026
The Legend Sc 300 is a motorized 3-wheeled vehicle classified under physical medicine. It is designed to provide mobility assistance for users.
This device has received FDA 510(k) clearance under the regulation number 890.3800. It is manufactured by Pride Health Care, Inc. and is identified by the product code INI.
Other devices from Pride Health Care, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary purpose of the Legend SC 300?
The Legend SC 300 is a motorized 3-wheeled vehicle classified under physical medicine, specifically designed to provide mobility assistance for users.
Has this device been reviewed by the FDA?
Yes, the Legend SC 300 has received FDA 510(k) clearance under regulation number 890.3800, identified by the product code INI.
Who is the manufacturer of this mobility vehicle?
The Legend SC 300 is manufactured by Pride Health Care, Inc., located in Pittston, Pennsylvania.