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FDA 510(k)

GLOBALCARE EMS

K-Number: K913444 · 1991-10-21

ApplicantGlobalcare Intl., Inc.
Decision Date1991-10-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GLOBALCARE EMS is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Intl., Inc.. It received FDA 510(k) clearance on 1991-10-21 under 510(k) number K913444. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBALCARE EMS?

GLOBALCARE EMS is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Globalcare Intl., Inc.. The 510(k) number is K913444.

When did GLOBALCARE EMS receive FDA 510(k) clearance?

GLOBALCARE EMS received FDA 510(k) clearance on 1991-10-21, under 510(k) number K913444.

Who is the listed applicant for GLOBALCARE EMS?

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

What is the FDA product code for GLOBALCARE EMS?

The FDA product code for GLOBALCARE EMS is IPF.

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 Globalcare Intl., 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.

K913373GLOBALCARE ELECTRODEK910244GLOBAL CARE MICRO IIK903394GLOBALCARE MICRO 11 AND MICROCARE (TENS)

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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