FDA 510(k)

EXTACISER PERINEAL MUSCLE EXERCISER

K-Number: K892888 · 1989-10-05

Decision Date1989-10-05

Product CodeHIR

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

EXTACISER PERINEAL MUSCLE EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1989-10-05 under 510(k) number K892888. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTACISER PERINEAL MUSCLE EXERCISER?

EXTACISER PERINEAL MUSCLE EXERCISER is a medical device that received FDA 510(k) clearance on 1989-10-05. The listed applicant is Bivona Medical Technologies. The 510(k) number is K892888.

When did EXTACISER PERINEAL MUSCLE EXERCISER receive FDA 510(k) clearance?

EXTACISER PERINEAL MUSCLE EXERCISER received FDA 510(k) clearance on 1989-10-05, under 510(k) number K892888.

Who is the listed applicant for EXTACISER PERINEAL MUSCLE EXERCISER?

The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTACISER PERINEAL MUSCLE EXERCISER?

The FDA product code for EXTACISER PERINEAL MUSCLE EXERCISER is HIR.

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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.