SOLAX

Vehicle, Motorized 3-wheeled

DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.

The following data is part of a premarket notification filed by Dongguan Prestige Sporting Goods Co., Ltd. with the FDA for Solax.

Pre-market Notification Details

• Device ID: K131302
• 510k Number: K131302
• Device Name: SOLAX
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. 16F-2(16A), NO. 462, SEC. 2 CHONGDE RD. BEITUN DIST. Taichung, TW 406
• Contact: Junnata Chang
• Correspondent: Junnata Chang; DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. 16F-2(16A), NO. 462, SEC. 2 CHONGDE RD. BEITUN DIST. Taichung, TW 406
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-07
• Decision Date: 2013-11-26
• Summary: summary