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FDA 510(k)

ISOSTATION KNEE MACHINE (K-100)

K-Number: K854621 · 1986-03-07

ApplicantIsotechnologies, Inc.
Decision Date1986-03-07
Product Code
DecisionSubstantially Equivalent

Device Summary

ISOSTATION KNEE MACHINE (K-100) is the device name listed in this FDA 510(k) record. The listed applicant is Isotechnologies, Inc.. It received FDA 510(k) clearance on 1986-03-07 under 510(k) number K854621. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOSTATION KNEE MACHINE (K-100)?

ISOSTATION KNEE MACHINE (K-100) is a medical device that received FDA 510(k) clearance on 1986-03-07. The listed applicant is Isotechnologies, Inc.. The 510(k) number is K854621.

When did ISOSTATION KNEE MACHINE (K-100) receive FDA 510(k) clearance?

ISOSTATION KNEE MACHINE (K-100) received FDA 510(k) clearance on 1986-03-07, under 510(k) number K854621.

Who is the listed applicant for ISOSTATION KNEE MACHINE (K-100)?

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

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.

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Other records listing Isotechnologies, 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.

K933063ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWAK912175ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWAREK844060ISOSTATION ANKLE/SUBTALAR MACHINE A-100K842296ISOSTATION LOWER BACK MACHINEK841849ISOSTATION SHOULDER MACHINE

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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