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FDA 510(k)

TE-800 PELVIC FLOOR EXERCISER

K-Number: K945937 · 1995-07-14

ApplicantMyo/Kinetic Systems, Inc.
Decision Date1995-07-14
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TE-800 PELVIC FLOOR EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Myo/Kinetic Systems, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K945937. 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 TE-800 PELVIC FLOOR EXERCISER?

TE-800 PELVIC FLOOR EXERCISER is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Myo/Kinetic Systems, Inc.. The 510(k) number is K945937.

When did TE-800 PELVIC FLOOR EXERCISER receive FDA 510(k) clearance?

TE-800 PELVIC FLOOR EXERCISER received FDA 510(k) clearance on 1995-07-14, under 510(k) number K945937.

Who is the listed applicant for TE-800 PELVIC FLOOR EXERCISER?

The FDA 510(k) record lists Myo/Kinetic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TE-800 PELVIC FLOOR EXERCISER?

The FDA product code for TE-800 PELVIC FLOOR EXERCISER is HIR.

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Other records listing Myo/Kinetic Systems, Inc. as applicant

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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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