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FDA 510(k)

4000 PT EXERCISE SYSTEM

K-Number: K912057 · 1991-10-24

ApplicantTri-Tech, Inc.
Decision Date1991-10-24
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

4000 PT EXERCISE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Tech, Inc.. It received FDA 510(k) clearance on 1991-10-24 under 510(k) number K912057. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4000 PT EXERCISE SYSTEM?

4000 PT EXERCISE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-24. The listed applicant is Tri-Tech, Inc.. The 510(k) number is K912057.

When did 4000 PT EXERCISE SYSTEM receive FDA 510(k) clearance?

4000 PT EXERCISE SYSTEM received FDA 510(k) clearance on 1991-10-24, under 510(k) number K912057.

Who is the listed applicant for 4000 PT EXERCISE SYSTEM?

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

What is the FDA product code for 4000 PT EXERCISE SYSTEM?

The FDA product code for 4000 PT EXERCISE SYSTEM is ISD.

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Other records listing Tri-Tech, 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.

K971111TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPERK952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITK922343TRI-TECH INC. CUSTOM SEXUAL ASSAULT KITK922342TRI-TECH INC. CUSTOM BLOOD ALCOHOLK912140STAIRMASTER MODEL 6000 ERGOMETERK912058GAUNTLET STAIR CLIMBER

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Related Devices (Code: ISD)

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.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K112121ERGOSELECT/GEErgoline GmbHK080545ACTITRAINERActigraph, LLCK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, Inc.

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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