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FDA 510(k)

THRESHOLD 2X INSPIRATORY MUSCLE TRAINER

K-Number: K912943 · 1992-01-30

ApplicantHealth Products, Inc.
Decision Date1992-01-30
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THRESHOLD 2X INSPIRATORY MUSCLE TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Health Products, Inc.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K912943. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THRESHOLD 2X INSPIRATORY MUSCLE TRAINER?

THRESHOLD 2X INSPIRATORY MUSCLE TRAINER is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Health Products, Inc.. The 510(k) number is K912943.

When did THRESHOLD 2X INSPIRATORY MUSCLE TRAINER receive FDA 510(k) clearance?

THRESHOLD 2X INSPIRATORY MUSCLE TRAINER received FDA 510(k) clearance on 1992-01-30, under 510(k) number K912943.

Who is the listed applicant for THRESHOLD 2X INSPIRATORY MUSCLE TRAINER?

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

What is the FDA product code for THRESHOLD 2X INSPIRATORY MUSCLE TRAINER?

The FDA product code for THRESHOLD 2X INSPIRATORY MUSCLE TRAINER is BWF.

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Other records listing Health 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.

K912866PEAK EXPIRATORY FLOW METERK911807METERED DOSE INHALER (MDI) SPACERK902292MODIFIED ASSESS(R) PEAK FLOW METERK896953MODIFIED ASSESS(R) PEAK FLOW METERK894353ORTHODERM CONVERTIBLEK890426CONSUMMATE AIR THERAPY BED

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Related Devices (Code: BWF)

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K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, Ltd.

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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