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FDA 510(k)

MFE COUCH ERGOMETER

K-Number: K850869 · 1985-06-12

ApplicantKetronic, Inc.
Decision Date1985-06-12
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MFE COUCH ERGOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ketronic, Inc.. It received FDA 510(k) clearance on 1985-06-12 under 510(k) number K850869. 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 MFE COUCH ERGOMETER?

MFE COUCH ERGOMETER is a medical device that received FDA 510(k) clearance on 1985-06-12. The listed applicant is Ketronic, Inc.. The 510(k) number is K850869.

When did MFE COUCH ERGOMETER receive FDA 510(k) clearance?

MFE COUCH ERGOMETER received FDA 510(k) clearance on 1985-06-12, under 510(k) number K850869.

Who is the listed applicant for MFE COUCH ERGOMETER?

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

What is the FDA product code for MFE COUCH ERGOMETER?

The FDA product code for MFE COUCH ERGOMETER is ISD.

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Other records listing Ketronic, 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.

K850873HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, ALK850877MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFORK850870MEDIFETTE ERGOMETERK850868MFE CARDIAC STRESS SYSTEMK850872PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STIK850871TREDBAND TYPE I, IT, II & III - TREADMILLS

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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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