510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K103771Substantially Equivalent

Lotus Blake Esteem Scooter

Letrix Power Hangzhou Pty, Ltd., Garden Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103771 is the FDA 510(k) clearance record for LOTUS BLAKE ESTEEM SCOOTER, a class II device, cleared for Letrix Power Hangzhou Pty, Ltd. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list one 510(k) clearance for Letrix Power Hangzhou Pty, Ltd. As of , FDA records show no recalls naming K103771.

Clearance record

Decision date
Received
(130 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Letrix Power Hangzhou Pty, Ltd. 10352 Stanford Rd., Garden Grove CA
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