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FDA 510(k)

TOTIM Patient Cushion Immobilization System

K-Number: K190894 · 2019-04-30

ApplicantEssebi Medical Srl
Decision Date2019-04-30
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOTIM Patient Cushion Immobilization System is a medical device manufactured by Essebi Medical Srl. It received FDA 510(k) clearance on 2019-04-30 under approval number K190894. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTIM Patient Cushion Immobilization System?

TOTIM Patient Cushion Immobilization System is a medical device that received FDA 510(k) clearance on 2019-04-30. It is manufactured by Essebi Medical Srl. The 510(k) number is K190894.

When was TOTIM Patient Cushion Immobilization System approved by the FDA?

TOTIM Patient Cushion Immobilization System received FDA 510(k) clearance on 2019-04-30, under approval number K190894.

What company makes TOTIM Patient Cushion Immobilization System?

TOTIM Patient Cushion Immobilization System is manufactured by Essebi Medical Srl.

What is the FDA product code for TOTIM Patient Cushion Immobilization System?

The FDA product code for TOTIM Patient Cushion Immobilization System is IYE.

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Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025)

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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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