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FDA 510(k)

MILEX KEGEL PERINEAL EXERCISER

K-Number: K862410 · 1986-07-31

ApplicantMilex Products, Inc.
Decision Date1986-07-31
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MILEX KEGEL PERINEAL EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Milex Products, Inc.. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K862410. 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 MILEX KEGEL PERINEAL EXERCISER?

MILEX KEGEL PERINEAL EXERCISER is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Milex Products, Inc.. The 510(k) number is K862410.

When did MILEX KEGEL PERINEAL EXERCISER receive FDA 510(k) clearance?

MILEX KEGEL PERINEAL EXERCISER received FDA 510(k) clearance on 1986-07-31, under 510(k) number K862410.

Who is the listed applicant for MILEX KEGEL PERINEAL EXERCISER?

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

What is the FDA product code for MILEX KEGEL PERINEAL EXERCISER?

The FDA product code for MILEX KEGEL PERINEAL EXERCISER is HIR.

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Other records listing Milex Products, 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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Related Devices (Code: HIR)

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.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

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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