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FDA 510(k)

REM 250 THREE WHEELED ELECTRIC CART

K-Number: K881766 · 1988-05-17

ApplicantRoyal Enterprises Manufacturing, Inc.
Decision Date1988-05-17
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REM 250 THREE WHEELED ELECTRIC CART is the device name listed in this FDA 510(k) record. The listed applicant is Royal Enterprises Manufacturing, Inc.. It received FDA 510(k) clearance on 1988-05-17 under 510(k) number K881766. 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 REM 250 THREE WHEELED ELECTRIC CART?

REM 250 THREE WHEELED ELECTRIC CART is a medical device that received FDA 510(k) clearance on 1988-05-17. The listed applicant is Royal Enterprises Manufacturing, Inc.. The 510(k) number is K881766.

When did REM 250 THREE WHEELED ELECTRIC CART receive FDA 510(k) clearance?

REM 250 THREE WHEELED ELECTRIC CART received FDA 510(k) clearance on 1988-05-17, under 510(k) number K881766.

Who is the listed applicant for REM 250 THREE WHEELED ELECTRIC CART?

The FDA 510(k) record lists Royal Enterprises Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REM 250 THREE WHEELED ELECTRIC CART?

The FDA product code for REM 250 THREE WHEELED ELECTRIC CART 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 Royal Enterprises Manufacturing, Inc. 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.

K872518REM500 THREE WHEELED ELEC. CART.

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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