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FDA 510(k)

PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER

K-Number: K031897 · 2003-09-23

ApplicantImc-Heart Way LLC
Decision Date2003-09-23
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER is the device name listed in this FDA 510(k) record. The listed applicant is Imc-Heart Way LLC. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K031897. 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 PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER?

PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Imc-Heart Way LLC. The 510(k) number is K031897.

When did PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER receive FDA 510(k) clearance?

PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER received FDA 510(k) clearance on 2003-09-23, under 510(k) number K031897.

Who is the listed applicant for PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER?

The FDA 510(k) record lists Imc-Heart Way LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER?

The FDA product code for PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER is INI.

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Other records listing Imc-Heart Way LLC 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.

K063328IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)K063320ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)K063307ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)K063203ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)K063475IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)K063474ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)

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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

View on FDA Database →

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

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