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FDA 510(k)

PREHENSILE HAND

K-Number: K791931 · 1979-10-04

ApplicantTherapeutic Recreation Systems, Inc.
Decision Date1979-10-04
Product CodeIRA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PREHENSILE 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 1979-10-04 under 510(k) number K791931. 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 PREHENSILE HAND?

PREHENSILE HAND is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Therapeutic Recreation Systems, Inc.. The 510(k) number is K791931.

When did PREHENSILE HAND receive FDA 510(k) clearance?

PREHENSILE HAND received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791931.

Who is the listed applicant for PREHENSILE 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 PREHENSILE HAND?

The FDA product code for PREHENSILE 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.

K821619THE SPORTS 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.

K821619THE SPORTS HANDTherapeutic Recreation Systems, 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.

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