510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062645Substantially Equivalent

Ruike, Model 3431

Shanghai Ruike Sports Goods Co., Ltd., Banqiao, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062645 is the FDA 510(k) clearance record for RUIKE, MODEL 3431, a class II device, cleared for Shanghai Ruike Sports Goods Co., Ltd. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 4 510(k) clearances for Shanghai Ruike Sports Goods Co., Ltd., from to . As of , FDA records show no recalls naming K062645.

Clearance record

Decision date
Received
(104 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Shanghai Ruike Sports Goods Co., Ltd. 14f-2, #1, Ln. 25, Banqiao, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code INI

Trailing 12 months
22 clearances under product code INI in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20262
October 20260