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FDA 510(k)

ELITE BIOFEEDBACK

K-Number: K942563 · 1995-06-06

ApplicantLaborie Medical Technologies, Ltd.
Decision Date1995-06-06
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELITE BIOFEEDBACK is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Technologies, Ltd.. It received FDA 510(k) clearance on 1995-06-06 under 510(k) number K942563. 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 ELITE BIOFEEDBACK?

ELITE BIOFEEDBACK is a medical device that received FDA 510(k) clearance on 1995-06-06. The listed applicant is Laborie Medical Technologies, Ltd.. The 510(k) number is K942563.

When did ELITE BIOFEEDBACK receive FDA 510(k) clearance?

ELITE BIOFEEDBACK received FDA 510(k) clearance on 1995-06-06, under 510(k) number K942563.

Who is the listed applicant for ELITE BIOFEEDBACK?

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

What is the FDA product code for ELITE BIOFEEDBACK?

The FDA product code for ELITE BIOFEEDBACK is HIR.

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Other records listing Laborie Medical Technologies, Ltd. 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.

K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPK962009UROSTYMK955856TEX-AID BLUEK955810U-TEXK951805PIPER, MODEL NUMBER UDS-PIPERBK942023INFUSION PUMP, MODEL NO. UDP-5

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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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