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FDA 510(k)

PELVICFLEXER EXERCISE DEVICE

K-Number: K011688 · 2002-03-20

ApplicantPelvicflex, Inc.
Decision Date2002-03-20
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PELVICFLEXER EXERCISE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pelvicflex, Inc.. It received FDA 510(k) clearance on 2002-03-20 under 510(k) number K011688. 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 PELVICFLEXER EXERCISE DEVICE?

PELVICFLEXER EXERCISE DEVICE is a medical device that received FDA 510(k) clearance on 2002-03-20. The listed applicant is Pelvicflex, Inc.. The 510(k) number is K011688.

When did PELVICFLEXER EXERCISE DEVICE receive FDA 510(k) clearance?

PELVICFLEXER EXERCISE DEVICE received FDA 510(k) clearance on 2002-03-20, under 510(k) number K011688.

Who is the listed applicant for PELVICFLEXER EXERCISE DEVICE?

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

What is the FDA product code for PELVICFLEXER EXERCISE DEVICE?

The FDA product code for PELVICFLEXER EXERCISE DEVICE is HIR.

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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

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

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