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)

BEWELL, MODEL SC 20

K-Number: K043326 · 2005-01-26

ApplicantCycling and Health Tech. Industry R&D Center
Decision Date2005-01-26
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BEWELL, MODEL SC 20 is the device name listed in this FDA 510(k) record. The listed applicant is Cycling and Health Tech. Industry R&D Center. It received FDA 510(k) clearance on 2005-01-26 under 510(k) number K043326. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEWELL, MODEL SC 20?

BEWELL, MODEL SC 20 is a medical device that received FDA 510(k) clearance on 2005-01-26. The listed applicant is Cycling and Health Tech. Industry R&D Center. The 510(k) number is K043326.

When did BEWELL, MODEL SC 20 receive FDA 510(k) clearance?

BEWELL, MODEL SC 20 received FDA 510(k) clearance on 2005-01-26, under 510(k) number K043326.

Who is the listed applicant for BEWELL, MODEL SC 20?

The FDA 510(k) record lists Cycling and Health Tech. Industry R&D Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEWELL, MODEL SC 20?

The FDA product code for BEWELL, MODEL SC 20 is INI.

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 Cycling and Health Tech. Industry R&D Center 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.

K050507SMARTECH, MODEL HOLI IK050793LANDLEX MODEL S400XK050792LANDLEX, MODEL S300XK043332WHEELCHAIR, MODEL 8500-II

Related Devices (Code: INI)

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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.

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.

↑