Companion Model 221, 321, 421
FDA 510(k) K012258 · Golden Technologies, Inc.
510(k) numberK012258
Submission
- Device name
- Companion Model 221, 321, 421
- Applicant
- Golden Technologies, Inc.
Old Forge, PA, US - Received
- July 18, 2001
- Decision date
- December 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K261232 | IERO Mobility Scooter (IERO-01)INI · Traditional | Jochu Technology Co., Ltd. | 07/14/2026SE |
| K261163 | Mobility Scooter (R200)INI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 06/08/2026SE |
| K253600 | Scooter (YD-03)INI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 06/03/2026SE |
| K260717 | Mobility Scooter (Air Carbon)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 05/20/2026SE |
| K260237 | Mobility Scooter (X-12, X-14, X-17)INI · Traditional | Wuyi Aichi Industry and Trade Co., Ltd. | 04/22/2026SE |
| K252813 | Electrical Scooter (SM4226)INI · Traditional | Lerado Zhongshan Peaceful Cove Business Trading… | 03/17/2026SE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
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 |
| K011153 | Alante, Battery Operated Power WheelchairITI · Traditional | 05/29/2001SE |
| K971050 | Golden HawkINI · Traditional | 08/01/1997SE |
| K971043 | Golden EagleINI · Traditional | 08/01/1997SE |
| K880800 | Golden Power Lift ChairINO · Traditional | 03/14/1988SE |
Questions and answers
When was Companion Model 221, 321, 421 cleared by the FDA?
Companion Model 221, 321, 421 (K012258) received a 510(k) decision of Substantially Equivalent on December 3, 2001, 138 days after the submission was received.
What is the product code of K012258?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.