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FDA 510(k)

MASSAGE MACHINE (CAT. EM-01 ULE 111756)

K-Number: K883064 · 1988-08-23

ApplicantEmrad, Ltd.
Decision Date1988-08-23
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MASSAGE MACHINE (CAT. EM-01 ULE 111756) is the device name listed in this FDA 510(k) record. The listed applicant is Emrad, Ltd.. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K883064. 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 MASSAGE MACHINE (CAT. EM-01 ULE 111756)?

MASSAGE MACHINE (CAT. EM-01 ULE 111756) is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is Emrad, Ltd.. The 510(k) number is K883064.

When did MASSAGE MACHINE (CAT. EM-01 ULE 111756) receive FDA 510(k) clearance?

MASSAGE MACHINE (CAT. EM-01 ULE 111756) received FDA 510(k) clearance on 1988-08-23, under 510(k) number K883064.

Who is the listed applicant for MASSAGE MACHINE (CAT. EM-01 ULE 111756)?

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

What is the FDA product code for MASSAGE MACHINE (CAT. EM-01 ULE 111756)?

The FDA product code for MASSAGE MACHINE (CAT. EM-01 ULE 111756) is ISA.

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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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