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FDA 510(k)

ISOSTATION ANKLE/SUBTALAR MACHINE A-100

K-Number: K844060 · 1984-11-23

ApplicantIsotechnologies, Inc.
Decision Date1984-11-23
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ISOSTATION ANKLE/SUBTALAR MACHINE A-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 1984-11-23 under 510(k) number K844060. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOSTATION ANKLE/SUBTALAR MACHINE A-100?

ISOSTATION ANKLE/SUBTALAR MACHINE A-100 is a medical device that received FDA 510(k) clearance on 1984-11-23. The listed applicant is Isotechnologies, Inc.. The 510(k) number is K844060.

When did ISOSTATION ANKLE/SUBTALAR MACHINE A-100 receive FDA 510(k) clearance?

ISOSTATION ANKLE/SUBTALAR MACHINE A-100 received FDA 510(k) clearance on 1984-11-23, under 510(k) number K844060.

Who is the listed applicant for ISOSTATION ANKLE/SUBTALAR MACHINE A-100?

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

What is the FDA product code for ISOSTATION ANKLE/SUBTALAR MACHINE A-100?

The FDA product code for ISOSTATION ANKLE/SUBTALAR MACHINE A-100 is IKK.

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 SOFTWAREK854621ISOSTATION KNEE MACHINE (K-100)K842296ISOSTATION LOWER BACK MACHINEK841849ISOSTATION SHOULDER MACHINE

Related Devices (Code: IKK)

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.

K123746AMES THERAPY DEVICEAmes Technology, Inc.K952090HUMAC SYSTEMComputer Sports Medicine, Inc.K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.K951916CC RIDER, MODEL ME180Mettler Electronics Corp.K950095CYBEX 770CybexK942229MOTIVATOR FTR 2000Hogan & Hartson

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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