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FDA 510(k)

BIO-STIM KIT

K-Number: K050174 · 2005-09-07

ApplicantSkylark Device & Systems Co., Ltd.
Decision Date2005-09-07
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIO-STIM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device & Systems Co., Ltd.. It received FDA 510(k) clearance on 2005-09-07 under 510(k) number K050174. 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 BIO-STIM KIT?

BIO-STIM KIT is a medical device that received FDA 510(k) clearance on 2005-09-07. The listed applicant is Skylark Device & Systems Co., Ltd.. The 510(k) number is K050174.

When did BIO-STIM KIT receive FDA 510(k) clearance?

BIO-STIM KIT received FDA 510(k) clearance on 2005-09-07, under 510(k) number K050174.

Who is the listed applicant for BIO-STIM KIT?

The FDA 510(k) record lists Skylark Device & Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-STIM KIT?

The FDA product code for BIO-STIM KIT is GZJ.

Other records listing Skylark Device & Systems Co., 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.

K053007SKYLARK URO PROBEK043306SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IRK034005SDS-4IK002832CONDUCTIVE GEL FOR ULTRASOUNDK992652SD-730 IF-SDS, PERFECT PULSE IF-SDS

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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