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FDA 510(k)

RESTRAINTS (VESTS AND JACKETS)

K-Number: K971536 · 1997-07-01

ApplicantE.M. Adams Co., Inc.
Decision Date1997-07-01
Product CodeFMQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RESTRAINTS (VESTS AND JACKETS) 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 1997-07-01 under 510(k) number K971536. 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 RESTRAINTS (VESTS AND JACKETS)?

RESTRAINTS (VESTS AND JACKETS) is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is E.M. Adams Co., Inc.. The 510(k) number is K971536.

When did RESTRAINTS (VESTS AND JACKETS) receive FDA 510(k) clearance?

RESTRAINTS (VESTS AND JACKETS) received FDA 510(k) clearance on 1997-07-01, under 510(k) number K971536.

Who is the listed applicant for RESTRAINTS (VESTS AND JACKETS)?

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 RESTRAINTS (VESTS AND JACKETS)?

The FDA product code for RESTRAINTS (VESTS AND JACKETS) 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.

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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.

K971948PATIENT RESTRAINT

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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