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)

EXTENSION CONTROL KNEE ORTHOSIS

K-Number: K832742 · 1983-09-20

ApplicantOrthomedics
Decision Date1983-09-20
Product CodeITM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXTENSION CONTROL KNEE ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Orthomedics. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832742. The device is classified under product code ITM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENSION CONTROL KNEE ORTHOSIS?

EXTENSION CONTROL KNEE ORTHOSIS is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Orthomedics. The 510(k) number is K832742.

When did EXTENSION CONTROL KNEE ORTHOSIS receive FDA 510(k) clearance?

EXTENSION CONTROL KNEE ORTHOSIS received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832742.

Who is the listed applicant for EXTENSION CONTROL KNEE ORTHOSIS?

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

What is the FDA product code for EXTENSION CONTROL KNEE ORTHOSIS?

The FDA product code for EXTENSION CONTROL KNEE ORTHOSIS is ITM.

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 Orthomedics 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.

K832740FEMORAL FRACTURE ORTHOSISK832741JASON CERVICAL ORTHOSISK811456ORTHO-FRAC KITK811297CERVICAL SUPPORTK811298EXECUTIVE COLLARK810555SCOLIOSIS ORTHOTIC SYSTEM

View all 16 devices →

Related Devices (Code: ITM)

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.

K812064POLI-AXIAL KNEE CAGEGeneration II Orthotics, Inc.K770899FRACTURE CAST BRACE, POLYChase Mfg. Co.K770900CAST BRWM, FRACTUREChase Mfg. Co.K760573IMPROVED KNEE DRESSINGRichard'S Medical Equip., Inc.

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.

↑