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FDA 510(k)

SUN-BURST

K-Number: K951120 · 1995-04-10

ApplicantKid'S Wheel-Chairs
Decision Date1995-04-10
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUN-BURST 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 1995-04-10 under 510(k) number K951120. 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 SUN-BURST?

SUN-BURST is a medical device that received FDA 510(k) clearance on 1995-04-10. The listed applicant is Kid'S Wheel-Chairs. The 510(k) number is K951120.

When did SUN-BURST receive FDA 510(k) clearance?

SUN-BURST received FDA 510(k) clearance on 1995-04-10, under 510(k) number K951120.

Who is the listed applicant for SUN-BURST?

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 SUN-BURST?

The FDA product code for SUN-BURST 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.

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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.

K964682SKYWAYK955295SPLASH & GO II

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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