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FDA 510(k)

GLOBALCARE MICRO 11 AND MICROCARE (TENS)

K-Number: K903394 · 1991-05-06

ApplicantGlobalcare Intl., Inc.
Decision Date1991-05-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GLOBALCARE MICRO 11 AND MICROCARE (TENS) 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 1991-05-06 under 510(k) number K903394. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBALCARE MICRO 11 AND MICROCARE (TENS)?

GLOBALCARE MICRO 11 AND MICROCARE (TENS) is a medical device that received FDA 510(k) clearance on 1991-05-06. The listed applicant is Globalcare Intl., Inc.. The 510(k) number is K903394.

When did GLOBALCARE MICRO 11 AND MICROCARE (TENS) receive FDA 510(k) clearance?

GLOBALCARE MICRO 11 AND MICROCARE (TENS) received FDA 510(k) clearance on 1991-05-06, under 510(k) number K903394.

Who is the listed applicant for GLOBALCARE MICRO 11 AND MICROCARE (TENS)?

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 MICRO 11 AND MICROCARE (TENS)?

The FDA product code for GLOBALCARE MICRO 11 AND MICROCARE (TENS) is GZJ.

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.

K913444GLOBALCARE EMSK913373GLOBALCARE ELECTRODEK910244GLOBAL CARE MICRO II

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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