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FDA 510(k)

510 DL POWERED WHEELCHAIRS

K-Number: K913989 · 1991-10-24

ApplicantAm Scooters
Decision Date1991-10-24
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

510 DL POWERED WHEELCHAIRS is the device name listed in this FDA 510(k) record. The listed applicant is Am Scooters. It received FDA 510(k) clearance on 1991-10-24 under 510(k) number K913989. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 510 DL POWERED WHEELCHAIRS?

510 DL POWERED WHEELCHAIRS is a medical device that received FDA 510(k) clearance on 1991-10-24. The listed applicant is Am Scooters. The 510(k) number is K913989.

When did 510 DL POWERED WHEELCHAIRS receive FDA 510(k) clearance?

510 DL POWERED WHEELCHAIRS received FDA 510(k) clearance on 1991-10-24, under 510(k) number K913989.

Who is the listed applicant for 510 DL POWERED WHEELCHAIRS?

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

What is the FDA product code for 510 DL POWERED WHEELCHAIRS?

The FDA product code for 510 DL POWERED WHEELCHAIRS is INI.

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 Am Scooters 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.

K922338X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTERK921467DRAKE & DRAKE/200 DL

Related Devices (Code: INI)

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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product 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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