510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070501Substantially Equivalent

Ruike 3421 Powered Wheelchair

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

K070501 is the FDA 510(k) clearance record for RUIKE 3421 POWERED WHEELCHAIR, a class II device, cleared for Shanghai Ruike Sports Goods Co., Ltd. on under FDA product code ITI (Wheelchair, Powered). FDA's definition for product code ITI reads: "A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to...". FDA records list 4 510(k) clearances for Shanghai Ruike Sports Goods Co., Ltd., from to . As of , FDA records show no recalls naming K070501.

Clearance record

Decision date
Received
(29 days to decision)
Product code
ITI Wheelchair, Powered
Regulation
21 CFR 890.3860
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 ITI

Trailing 12 months
36 clearances under product code ITI in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code ITI, trailing twelve months
MonthClearances
November 20253
December 20253
January 20262
February 20263
March 20267
April 20263
May 20261
June 20266
July 20263
August 20261
September 20264
October 20260