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)

PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3

K-Number: K020001 · 2002-03-21

ApplicantTransworld Mobility Distribution, LLC
Decision Date2002-03-21
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 is the device name listed in this FDA 510(k) record. The listed applicant is Transworld Mobility Distribution, LLC. It received FDA 510(k) clearance on 2002-03-21 under 510(k) number K020001. 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 PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3?

PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 is a medical device that received FDA 510(k) clearance on 2002-03-21. The listed applicant is Transworld Mobility Distribution, LLC. The 510(k) number is K020001.

When did PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 receive FDA 510(k) clearance?

PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 received FDA 510(k) clearance on 2002-03-21, under 510(k) number K020001.

Who is the listed applicant for PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3?

The FDA 510(k) record lists Transworld Mobility Distribution, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3?

The FDA product code for PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 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 Transworld Mobility Distribution, LLC 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.

K020002MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33K011745HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIRK011744HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

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.

↑