510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110068Substantially Equivalent

Model Pm3030

Omron Healthcare Co., Ltd., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110068 is the FDA 510(k) clearance record for MODEL PM3030, a class II device, cleared for Omron Healthcare, Inc. on under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter). FDA's definition for product code NUH reads: "TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES". FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K110068.

Clearance record

Decision date
Received
(332 days to decision)
Product code
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Omron Healthcare, Inc. 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUH

Trailing 12 months
10 clearances under product code NUH in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NUH, trailing twelve months
MonthClearances
November 20253
December 20253
January 20260
February 20260
March 20261
April 20260
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260