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)

THE ROBOLITE

K-Number: K964460 · 1997-01-24

ApplicantShai Syg Motion and Innovations, Ltd.
Decision Date1997-01-24
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE ROBOLITE is the device name listed in this FDA 510(k) record. The listed applicant is Shai Syg Motion and Innovations, Ltd.. It received FDA 510(k) clearance on 1997-01-24 under 510(k) number K964460. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ROBOLITE?

THE ROBOLITE is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is Shai Syg Motion and Innovations, Ltd.. The 510(k) number is K964460.

When did THE ROBOLITE receive FDA 510(k) clearance?

THE ROBOLITE received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964460.

Who is the listed applicant for THE ROBOLITE?

The FDA 510(k) record lists Shai Syg Motion and Innovations, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE ROBOLITE?

The FDA product code for THE ROBOLITE is JQP.

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 Shai Syg Motion and Innovations, Ltd. 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.

K961849THE ROBOGUIDE

Related Devices (Code: JQP)

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.

K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime CorporationK983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.K953652PRENVAL IBase Ten Systems, Inc.K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, Inc.K893838MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZERCiba Corning Diagnostics Corp.

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.

↑