Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MS-ONE, MODEL MS-1

K-Number: K003258 · 2001-01-12

ApplicantHome Wellness West
Decision Date2001-01-12
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MS-ONE, MODEL MS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Home Wellness West. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K003258. 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 MS-ONE, MODEL MS-1?

MS-ONE, MODEL MS-1 is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Home Wellness West. The 510(k) number is K003258.

When did MS-ONE, MODEL MS-1 receive FDA 510(k) clearance?

MS-ONE, MODEL MS-1 received FDA 510(k) clearance on 2001-01-12, under 510(k) number K003258.

Who is the listed applicant for MS-ONE, MODEL MS-1?

The FDA 510(k) record lists Home Wellness West as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MS-ONE, MODEL MS-1?

The FDA product code for MS-ONE, MODEL MS-1 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Home Wellness West 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.

K994065MS-ONE, MODEL MS-1

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑