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FDA 510(k)

THE SPORTS HAND

K-Number: K821619 · 1982-07-20

ApplicantTherapeutic Recreation Systems, Inc.
Decision Date1982-07-20
Product CodeIRA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE SPORTS HAND is the device name listed in this FDA 510(k) record. The listed applicant is Therapeutic Recreation Systems, Inc.. It received FDA 510(k) clearance on 1982-07-20 under 510(k) number K821619. The device is classified under product code IRA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SPORTS HAND?

THE SPORTS HAND is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is Therapeutic Recreation Systems, Inc.. The 510(k) number is K821619.

When did THE SPORTS HAND receive FDA 510(k) clearance?

THE SPORTS HAND received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821619.

Who is the listed applicant for THE SPORTS HAND?

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

What is the FDA product code for THE SPORTS HAND?

The FDA product code for THE SPORTS HAND is IRA.

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 Therapeutic Recreation Systems, 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.

K791931PREHENSILE HAND

Related Devices (Code: IRA)

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.

K791931PREHENSILE HANDTherapeutic Recreation Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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