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)

TOOL-LESS WHEEL CHAIR

K-Number: K972797 · 1997-08-12

ApplicantSunrise Medical, Inc.
Decision Date1997-08-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TOOL-LESS WHEEL CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical, Inc.. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K972797. 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 TOOL-LESS WHEEL CHAIR?

TOOL-LESS WHEEL CHAIR is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Sunrise Medical, Inc.. The 510(k) number is K972797.

When did TOOL-LESS WHEEL CHAIR receive FDA 510(k) clearance?

TOOL-LESS WHEEL CHAIR received FDA 510(k) clearance on 1997-08-12, under 510(k) number K972797.

Who is the listed applicant for TOOL-LESS WHEEL CHAIR?

The FDA 510(k) record lists Sunrise Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOOL-LESS WHEEL CHAIR?

The FDA product code for TOOL-LESS WHEEL CHAIR 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 Sunrise Medical, 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.

K072153QUICKIE QX MANUAL FOLDING WHEELCHAIRK062701QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIRK031289QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424K011268BREEZY WHEELCHAIR, MODEL 300K010917POWER TILT AND RECLINE SYSTEMK001491QUICKIE 2 POWER ASSIST WHEELCHAIR

View all 19 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.

↑