Proasia, Model L3402
FDA 510(k) K052378 · Proasia Limited
510(k) numberK052378
Submission
- Device name
- Proasia, Model L3402
- Applicant
- Proasia Limited
Beitun District, Taichung, TW - Received
- August 30, 2005
- Decision date
- October 7, 2005
- 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 |
|---|---|---|
| K052486 | Proasia, Model L4501INI · Traditional | 10/07/2005SE |
Questions and answers
When was Proasia, Model L3402 cleared by the FDA?
Proasia, Model L3402 (K052378) received a 510(k) decision of Substantially Equivalent on October 7, 2005, 38 days after the submission was received.
What is the product code of K052378?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.