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)

ECLIPSE 400 MANUALLY OPERATED WHEELCAIR

K-Number: K971389 · 1997-05-09

ApplicantPdg Product Design Group, Inc.
Decision Date1997-05-09
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ECLIPSE 400 MANUALLY OPERATED WHEELCAIR is the device name listed in this FDA 510(k) record. The listed applicant is Pdg Product Design Group, Inc.. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K971389. 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 ECLIPSE 400 MANUALLY OPERATED WHEELCAIR?

ECLIPSE 400 MANUALLY OPERATED WHEELCAIR is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Pdg Product Design Group, Inc.. The 510(k) number is K971389.

When did ECLIPSE 400 MANUALLY OPERATED WHEELCAIR receive FDA 510(k) clearance?

ECLIPSE 400 MANUALLY OPERATED WHEELCAIR received FDA 510(k) clearance on 1997-05-09, under 510(k) number K971389.

Who is the listed applicant for ECLIPSE 400 MANUALLY OPERATED WHEELCAIR?

The FDA 510(k) record lists Pdg Product Design Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECLIPSE 400 MANUALLY OPERATED WHEELCAIR?

The FDA product code for ECLIPSE 400 MANUALLY OPERATED WHEELCAIR 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 Pdg Product Design Group, Inc. 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.

K163432Stellar LEAPK063736FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50K061475ASTROTILT MANUAL WHEELCHAIRK990557THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIRK970311BENTLEY MANUALLY OPERATED WHEELCHAIRK961743ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR

View all 7 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.

↑