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)

BRACE C.T.

K-Number: K831310 · 1983-05-16

ApplicantInnovation Sports, Inc.
Decision Date1983-05-16
Product CodeITQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BRACE C.T. is the device name listed in this FDA 510(k) record. The listed applicant is Innovation Sports, Inc.. It received FDA 510(k) clearance on 1983-05-16 under 510(k) number K831310. The device is classified under product code ITQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRACE C.T.?

BRACE C.T. is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is Innovation Sports, Inc.. The 510(k) number is K831310.

When did BRACE C.T. receive FDA 510(k) clearance?

BRACE C.T. received FDA 510(k) clearance on 1983-05-16, under 510(k) number K831310.

Who is the listed applicant for BRACE C.T.?

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

What is the FDA product code for BRACE C.T.?

The FDA product code for BRACE C.T. is ITQ.

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 Innovation Sports, Inc. 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.

K940858THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)

Related Devices (Code: ITQ)

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.

K831044LIMITED MOTION FUNCTIONAL KNEE BRACEOrthopedic Systems, Inc.K823658DELUXE KNEE IMMOBILIZER(UNIVERSAL)Warm & Form, Orthopedic MaterialsK823397ANATOMIC FRACTURE BRACEOrthopedic Systems, Inc.K823159DELUXE KNEE IMMOBILIZERWarm & Form, Orthopedic MaterialsK812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, Inc.K812094AIRCAST PNEUMATIC KNEE BRACEAircast, 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.

↑