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FDA 510(k)

PATIENT RESTRAINT

K-Number: K971948 · 1997-08-06

ApplicantE.M. Adams Co., Inc.
Decision Date1997-08-06
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT RESTRAINT is the device name listed in this FDA 510(k) record. The listed applicant is E.M. Adams Co., Inc.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K971948. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT RESTRAINT?

PATIENT RESTRAINT is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is E.M. Adams Co., Inc.. The 510(k) number is K971948.

When did PATIENT RESTRAINT receive FDA 510(k) clearance?

PATIENT RESTRAINT received FDA 510(k) clearance on 1997-08-06, under 510(k) number K971948.

Who is the listed applicant for PATIENT RESTRAINT?

The FDA 510(k) record lists E.M. Adams Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT RESTRAINT?

The FDA product code for PATIENT RESTRAINT is FMQ.

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 E.M. Adams Co., 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.

K971536RESTRAINTS (VESTS AND JACKETS)

Related Devices (Code: FMQ)

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.

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

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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