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)

OMEGA TRAC, MODEL Z100

K-Number: K993160 · 1999-11-18

ApplicantTeftec Corp.
Decision Date1999-11-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMEGA TRAC, MODEL Z100 is the device name listed in this FDA 510(k) record. The listed applicant is Teftec Corp.. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K993160. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA TRAC, MODEL Z100?

OMEGA TRAC, MODEL Z100 is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Teftec Corp.. The 510(k) number is K993160.

When did OMEGA TRAC, MODEL Z100 receive FDA 510(k) clearance?

OMEGA TRAC, MODEL Z100 received FDA 510(k) clearance on 1999-11-18, under 510(k) number K993160.

Who is the listed applicant for OMEGA TRAC, MODEL Z100?

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

What is the FDA product code for OMEGA TRAC, MODEL Z100?

The FDA product code for OMEGA TRAC, MODEL Z100 is ITI.

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 Teftec Corp. 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.

K022652ALPHATRAC, MODEL A 205K013307OMEGATRAC, MODEL Z105K992627FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500K992628FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400K983066FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300K982815ALPHATRAC, MODEL A200

View all 8 devices →

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

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.

↑