510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935459Substantially Equivalent

Omron Massager Model Hm-45

Omron Healthcare Co., Ltd., Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935459 is the FDA 510(k) clearance record for OMRON MASSAGER MODEL HM-45, a class I device, cleared for Omron Healthcare, Inc. on under FDA product code ISA (Massager, Therapeutic, Electric). FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K935459.

Clearance record

Decision date
Received
(112 days to decision)
Product code
ISA Massager, Therapeutic, Electric
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Omron Healthcare, Inc. 300 Lakeview Pkwy., Vernon Hills IL
510(k) summary
Statement
Third party review
No

Clearances, product code ISA

Trailing 12 months

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

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