Golden Hawk
by Golden Technologies, Inc. 510(k)
Active
510(k) K971050
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971050 | Date1 Aug 1997 | 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- Withdrawn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, 25 Sep 2026
The Golden Hawk is a motorized 3-wheeled vehicle. It is classified as a device with a regulation number of 890.3800 and a product code of INI.
The Golden Hawk is supplied by Golden Technologies, Inc. and has been authorized with an FDA 510K clearance. It is used in the field of Physical Medicine.
Other devices from Golden Technologies, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Golden Hawk used for?
The Golden Hawk is used in the field of Physical Medicine, indicating its application in rehabilitation and therapy.
Is the Golden Hawk a single-use or reusable device?
The device data does not specify whether the Golden Hawk is single-use or reusable, suggesting that its intended use is likely for repeated use with proper maintenance.
What regulatory authorization has the Golden Hawk received?
The Golden Hawk has been authorized with an FDA 510K clearance, indicating that it has been found to be substantially equivalent to a predicate device.
Who manufactures the Golden Hawk?
The Golden Hawk is manufactured by Golden Technologies, Inc., a company based in the US.