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FDA 510(k)

X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER

K-Number: K922338 · 1992-06-11

ApplicantAm Scooters
Decision Date1992-06-11
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER is the device name listed in this FDA 510(k) record. The listed applicant is Am Scooters. It received FDA 510(k) clearance on 1992-06-11 under 510(k) number K922338. 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 X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER?

X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER is a medical device that received FDA 510(k) clearance on 1992-06-11. The listed applicant is Am Scooters. The 510(k) number is K922338.

When did X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER receive FDA 510(k) clearance?

X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER received FDA 510(k) clearance on 1992-06-11, under 510(k) number K922338.

Who is the listed applicant for X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER?

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 X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER?

The FDA product code for X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER 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.

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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.

K921467DRAKE & DRAKE/200 DLK913989510 DL POWERED WHEELCHAIRS

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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