510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K041187Substantially Equivalent

A&i Scooter, Sc-301

Well Success Biotech, Inc., Hsin Chu City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041187 is the FDA 510(k) clearance record for A&I SCOOTER, SC-301, a class II device, cleared for Well Success Biotech, Inc. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 3 510(k) clearances for Well Success Biotech, Inc. As of , FDA records show no recalls naming K041187.

Clearance record

Decision date
Received
(19 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Well Success Biotech, Inc. 58 Fu-Chiun St., Hsin Chu City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code INI

Trailing 12 months
24 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 20264
October 20260