510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021371Substantially Equivalent

Sunspex Technologies Model Se 02

Sunpex Technology Co., Ltd., Chia Yi City, TW / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K021371 is the FDA 510(k) clearance record for SUNSPEX TECHNOLOGIES MODEL SE 02, a class II device, cleared for Sunpex Technology Co., Ltd. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 4 510(k) clearances for Sunpex Technology Co., Ltd., from to . As of , FDA records show no recalls naming K021371.

Clearance record

Decision date
Received
(16 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Sunpex Technology Co., Ltd. 676 Chung Hsiao Rd., Chia Yi City, TW
510(k) summary
Statement
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