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FDA 510(k)

TRU-KINETICS (TM)

K-Number: K862780 · 1986-08-04

ApplicantTru-Trac
Decision Date1986-08-04
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRU-KINETICS (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Tru-Trac. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K862780. 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 TRU-KINETICS (TM)?

TRU-KINETICS (TM) is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Tru-Trac. The 510(k) number is K862780.

When did TRU-KINETICS (TM) receive FDA 510(k) clearance?

TRU-KINETICS (TM) received FDA 510(k) clearance on 1986-08-04, under 510(k) number K862780.

Who is the listed applicant for TRU-KINETICS (TM)?

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

What is the FDA product code for TRU-KINETICS (TM)?

The FDA product code for TRU-KINETICS (TM) 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 Tru-Trac 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.

K893448TRU TRAC TRACTION TABLEK862579TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000

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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