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FDA 510(k)

AQUATREX UNDERWATER TREADMILL SYSTEM

K-Number: K895104 · 1989-12-04

ApplicantEdmonds Medical Systems
Decision Date1989-12-04
Product CodeIOL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AQUATREX UNDERWATER TREADMILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Edmonds Medical Systems. It received FDA 510(k) clearance on 1989-12-04 under 510(k) number K895104. The device is classified under product code IOL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUATREX UNDERWATER TREADMILL SYSTEM?

AQUATREX UNDERWATER TREADMILL SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-04. The listed applicant is Edmonds Medical Systems. The 510(k) number is K895104.

When did AQUATREX UNDERWATER TREADMILL SYSTEM receive FDA 510(k) clearance?

AQUATREX UNDERWATER TREADMILL SYSTEM received FDA 510(k) clearance on 1989-12-04, under 510(k) number K895104.

Who is the listed applicant for AQUATREX UNDERWATER TREADMILL SYSTEM?

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

What is the FDA product code for AQUATREX UNDERWATER TREADMILL SYSTEM?

The FDA product code for AQUATREX UNDERWATER TREADMILL SYSTEM is IOL.

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Related Devices (Code: IOL)

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.

K950376PARKER MODEL PMParker Treadmill Co., Inc.K950377PARKER MODEL PEParker Treadmill Co., Inc.K925839TRACKMASTERJas Manufacturing Co., Inc.K930261RTM REHABILITATION TREADMILL, MODEL #945-200Biodan Medical Systems, Ltd.K904556MANSFIELD CARDIAC ASSIST MODEL 940(TM) IABBoston Scientific CorpK913518TA620 TREADMILL CONTROLLERSiemens Burdick, Inc.

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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