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FDA 510(k)

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE

K-Number: K952688 · 1995-12-06

ApplicantEmpi
Decision Date1995-12-06
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1995-12-06 under 510(k) number K952688. 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 INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE?

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Empi. The 510(k) number is K952688.

When did INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE receive FDA 510(k) clearance?

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE received FDA 510(k) clearance on 1995-12-06, under 510(k) number K952688.

Who is the listed applicant for INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE?

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

What is the FDA product code for INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE?

The FDA product code for INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE is HIR.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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Related Devices (Code: HIR)

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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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