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FDA 510(k)

ISOSTATION SHOULDER MACHINE

K-Number: K841849 · 1984-05-14

ApplicantIsotechnologies, Inc.
Decision Date1984-05-14
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ISOSTATION SHOULDER MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Isotechnologies, Inc.. It received FDA 510(k) clearance on 1984-05-14 under 510(k) number K841849. 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 SHOULDER MACHINE?

ISOSTATION SHOULDER MACHINE is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Isotechnologies, Inc.. The 510(k) number is K841849.

When did ISOSTATION SHOULDER MACHINE receive FDA 510(k) clearance?

ISOSTATION SHOULDER MACHINE received FDA 510(k) clearance on 1984-05-14, under 510(k) number K841849.

Who is the listed applicant for ISOSTATION SHOULDER MACHINE?

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 SHOULDER MACHINE?

The FDA product code for ISOSTATION SHOULDER MACHINE 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.

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

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)K844060ISOSTATION ANKLE/SUBTALAR MACHINE A-100K842296ISOSTATION LOWER BACK 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

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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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