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FDA 510(k)

MODEL SW-103 SOLITANS STIMULATOR

K-Number: K904264 · 1991-05-09

ApplicantMedical Consultants Intl. , Ltd.
Decision Date1991-05-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL SW-103 SOLITANS STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Consultants Intl. , Ltd.. It received FDA 510(k) clearance on 1991-05-09 under 510(k) number K904264. 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 MODEL SW-103 SOLITANS STIMULATOR?

MODEL SW-103 SOLITANS STIMULATOR is a medical device that received FDA 510(k) clearance on 1991-05-09. The listed applicant is Medical Consultants Intl. , Ltd.. The 510(k) number is K904264.

When did MODEL SW-103 SOLITANS STIMULATOR receive FDA 510(k) clearance?

MODEL SW-103 SOLITANS STIMULATOR received FDA 510(k) clearance on 1991-05-09, under 510(k) number K904264.

Who is the listed applicant for MODEL SW-103 SOLITANS STIMULATOR?

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

What is the FDA product code for MODEL SW-103 SOLITANS STIMULATOR?

The FDA product code for MODEL SW-103 SOLITANS STIMULATOR 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 Medical Consultants Intl. , Ltd. 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.

K900731MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)K903654LISS CRANIAL STIMULATOR MODEL SBL202-BK902976MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DCK894515LISS CRANIAL STIMULATOR MODEL SBL201-MK896226LISS BODY STIMULATOR MODEL SBL501-M

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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