FDA 510(k)

U66 EMS

K-Number: K864558 · 1986-12-29

ApplicantSuntec Health & Fitness Group, Inc.

Decision Date1986-12-29

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent for Some Indications

Device Summary

U66 EMS is the device name listed in this FDA 510(k) record. The listed applicant is Suntec Health & Fitness Group, Inc.. It received FDA 510(k) clearance on 1986-12-29 under 510(k) number K864558. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the U66 EMS?

U66 EMS is a medical device that received FDA 510(k) clearance on 1986-12-29. The listed applicant is Suntec Health & Fitness Group, Inc.. The 510(k) number is K864558.

When did U66 EMS receive FDA 510(k) clearance?

U66 EMS received FDA 510(k) clearance on 1986-12-29, under 510(k) number K864558.

Who is the listed applicant for U66 EMS?

The FDA 510(k) record lists Suntec Health & Fitness Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U66 EMS?

The FDA product code for U66 EMS is IPF.

Other records listing Suntec Health & Fitness Group, 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.

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Official Source

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