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FDA 510(k)

ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR

K-Number: K894345 · 1989-07-27

ApplicantDamaco
Decision Date1989-07-27
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Damaco. It received FDA 510(k) clearance on 1989-07-27 under 510(k) number K894345. 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 ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR?

ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1989-07-27. The listed applicant is Damaco. The 510(k) number is K894345.

When did ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR receive FDA 510(k) clearance?

ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR received FDA 510(k) clearance on 1989-07-27, under 510(k) number K894345.

Who is the listed applicant for ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR?

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

What is the FDA product code for ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR?

The FDA product code for ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR 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 Damaco 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.

K970575ELECTRO-LITE ELITE POWERED WHEELCHAIRK894346D88VS WHEELCHAIR POWER SYSTEMK894344ELECTRO-LITE POWER WHEELCHAIR

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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