510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031621Substantially Equivalent

Hero 1, Model Ly-Esb220

Comfort Orthopedic Co., Ltd., Chia-Yi, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031621 is the FDA 510(k) clearance record for HERO 1, MODEL LY-ESB220, a class II device, cleared for Comfort Orthopedic Co., Ltd. on under FDA product code IPL (Wheelchair, Standup). FDA records list 13 510(k) clearances for Comfort Orthopedic Co., Ltd., from to . As of , FDA records show no recalls naming K031621.

Clearance record

Decision date
Received
(244 days to decision)
Product code
IPL Wheelchair, Standup
Regulation
21 CFR 890.3900
Device class
Class II
Review panel
Physical Medicine
Applicant
Comfort Orthopedic Co., Ltd. # 120 Nan Shiang Tsuen,, Chia-Yi, TW
510(k) summary
Statement
Third party review
No

Clearances, product code IPL

Trailing 12 months

FDA records hold no clearances under product code IPL in the trailing twelve months.

FDA records show no clearances under product code IPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260