Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GOLDEN MEAN MACHINE(TM) (CLASS 2)

K-Number: K890401 · 1989-04-21

ApplicantBennett Ergonomic Labs, Inc.
Decision Date1989-04-21
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GOLDEN MEAN MACHINE(TM) (CLASS 2) is the device name listed in this FDA 510(k) record. The listed applicant is Bennett Ergonomic Labs, Inc.. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K890401. 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 GOLDEN MEAN MACHINE(TM) (CLASS 2)?

GOLDEN MEAN MACHINE(TM) (CLASS 2) is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Bennett Ergonomic Labs, Inc.. The 510(k) number is K890401.

When did GOLDEN MEAN MACHINE(TM) (CLASS 2) receive FDA 510(k) clearance?

GOLDEN MEAN MACHINE(TM) (CLASS 2) received FDA 510(k) clearance on 1989-04-21, under 510(k) number K890401.

Who is the listed applicant for GOLDEN MEAN MACHINE(TM) (CLASS 2)?

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

What is the FDA product code for GOLDEN MEAN MACHINE(TM) (CLASS 2)?

The FDA product code for GOLDEN MEAN MACHINE(TM) (CLASS 2) is ISD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑