Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMRON TRAVEL MASSAGER, MODEL HM-01

K-Number: K893029 · 1989-05-31

Decision Date1989-05-31
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMRON TRAVEL MASSAGER, MODEL HM-01 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Electronics, Inc.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K893029. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMRON TRAVEL MASSAGER, MODEL HM-01?

OMRON TRAVEL MASSAGER, MODEL HM-01 is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Omron Electronics, Inc.. The 510(k) number is K893029.

When did OMRON TRAVEL MASSAGER, MODEL HM-01 receive FDA 510(k) clearance?

OMRON TRAVEL MASSAGER, MODEL HM-01 received FDA 510(k) clearance on 1989-05-31, under 510(k) number K893029.

Who is the listed applicant for OMRON TRAVEL MASSAGER, MODEL HM-01?

The FDA 510(k) record lists Omron Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMRON TRAVEL MASSAGER, MODEL HM-01?

The FDA product code for OMRON TRAVEL MASSAGER, MODEL HM-01 is ISA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Omron Electronics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: ISA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑