Golden Hawk
FDA 510(k) K971050 · Golden Technologies, Inc.
510(k) numberK971050
Submission
- Device name
- Golden Hawk
- Applicant
- Golden Technologies, Inc.
Old Forge, PA, US - Received
- March 21, 1997
- Decision date
- August 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
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More from Nanjing Mijo Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K063162 | Golden LitewayINI · Special | 11/02/2006SE |
| K041341 | Golden Spyder, Model GS-300ITI · Special | 06/03/2004SE |
| K041025 | Buzzaround, Vehicle, Motorized 3-WHEELEDINI · Special | 05/03/2004SE |
| K012258 | Companion Model 221, 321, 421INI · Traditional | 12/03/2001SE |
| K011153 | Alante, Battery Operated Power WheelchairITI · Traditional | 05/29/2001SE |
| K971043 | Golden EagleINI · Traditional | 08/01/1997SE |
| K880800 | Golden Power Lift ChairINO · Traditional | 03/14/1988SE |
Questions and answers
When was Golden Hawk cleared by the FDA?
Golden Hawk (K971050) received a 510(k) decision of Substantially Equivalent on August 1, 1997, 133 days after the submission was received.
What is the product code of K971050?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.