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FDA 510(k)

OMBRON TWIN-HEAD MASSAGER MODEL HM-101

K-Number: K935462 · 1994-03-04

ApplicantOmron Healthcare, Inc.
Decision Date1994-03-04
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMBRON TWIN-HEAD MASSAGER MODEL HM-101 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 1994-03-04 under 510(k) number K935462. 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 OMBRON TWIN-HEAD MASSAGER MODEL HM-101?

OMBRON TWIN-HEAD MASSAGER MODEL HM-101 is a medical device that received FDA 510(k) clearance on 1994-03-04. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K935462.

When did OMBRON TWIN-HEAD MASSAGER MODEL HM-101 receive FDA 510(k) clearance?

OMBRON TWIN-HEAD MASSAGER MODEL HM-101 received FDA 510(k) clearance on 1994-03-04, under 510(k) number K935462.

Who is the listed applicant for OMBRON TWIN-HEAD MASSAGER MODEL HM-101?

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

What is the FDA product code for OMBRON TWIN-HEAD MASSAGER MODEL HM-101?

The FDA product code for OMBRON TWIN-HEAD MASSAGER MODEL HM-101 is ISA.

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Other records listing Omron Healthcare, Inc. as applicant

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Related Devices (Code: ISA)

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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.

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