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FDA 510(k)

HITACHI HAND HELD MASSAGER A/C POWERED

K-Number: K864088 · 1986-11-03

ApplicantHitachi Sales Corporation of America
Decision Date1986-11-03
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HITACHI HAND HELD MASSAGER A/C POWERED is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Sales Corporation of America. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K864088. 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 HITACHI HAND HELD MASSAGER A/C POWERED?

HITACHI HAND HELD MASSAGER A/C POWERED is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Hitachi Sales Corporation of America. The 510(k) number is K864088.

When did HITACHI HAND HELD MASSAGER A/C POWERED receive FDA 510(k) clearance?

HITACHI HAND HELD MASSAGER A/C POWERED received FDA 510(k) clearance on 1986-11-03, under 510(k) number K864088.

Who is the listed applicant for HITACHI HAND HELD MASSAGER A/C POWERED?

The FDA 510(k) record lists Hitachi Sales Corporation of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HITACHI HAND HELD MASSAGER A/C POWERED?

The FDA product code for HITACHI HAND HELD MASSAGER A/C POWERED is ISA.

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Other records listing Hitachi Sales Corporation of America 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.

K864089HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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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