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)

LITESTREAM 500E

K-Number: K042444 · 2004-10-21

ApplicantPride Mobility Products Corp.
Decision Date2004-10-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LITESTREAM 500E is the device name listed in this FDA 510(k) record. The listed applicant is Pride Mobility Products Corp.. It received FDA 510(k) clearance on 2004-10-21 under 510(k) number K042444. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITESTREAM 500E?

LITESTREAM 500E is a medical device that received FDA 510(k) clearance on 2004-10-21. The listed applicant is Pride Mobility Products Corp.. The 510(k) number is K042444.

When did LITESTREAM 500E receive FDA 510(k) clearance?

LITESTREAM 500E received FDA 510(k) clearance on 2004-10-21, under 510(k) number K042444.

Who is the listed applicant for LITESTREAM 500E?

The FDA 510(k) record lists Pride Mobility Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITESTREAM 500E?

The FDA product code for LITESTREAM 500E is IOR.

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 Pride Mobility Products Corp. 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.

K111739KIDS ROCK 3 CHAIRK091578LIFT CHAIR, MODEL T3K092961JAZZY FRONTIEK092088VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713K091113MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940VK090805V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710

View all 20 devices →

Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply 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.

↑