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)

SPLASH & GO II

K-Number: K955295 · 1995-11-30

ApplicantKid'S Wheel-Chairs
Decision Date1995-11-30
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPLASH & GO II is the device name listed in this FDA 510(k) record. The listed applicant is Kid'S Wheel-Chairs. It received FDA 510(k) clearance on 1995-11-30 under 510(k) number K955295. 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 SPLASH & GO II?

SPLASH & GO II is a medical device that received FDA 510(k) clearance on 1995-11-30. The listed applicant is Kid'S Wheel-Chairs. The 510(k) number is K955295.

When did SPLASH & GO II receive FDA 510(k) clearance?

SPLASH & GO II received FDA 510(k) clearance on 1995-11-30, under 510(k) number K955295.

Who is the listed applicant for SPLASH & GO II?

The FDA 510(k) record lists Kid'S Wheel-Chairs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPLASH & GO II?

The FDA product code for SPLASH & GO II 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 Kid'S Wheel-Chairs 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.

K964682SKYWAYK951120SUN-BURST

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.

↑