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FDA 510(k)

AMIGO J-9

K-Number: K940334 · 1994-05-18

ApplicantAmigo Mobility Intl., Inc.
Decision Date1994-05-18
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

AMIGO J-9 is the device name listed in this FDA 510(k) record. The listed applicant is Amigo Mobility Intl., Inc.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K940334. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AMIGO J-9?

AMIGO J-9 is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Amigo Mobility Intl., Inc.. The 510(k) number is K940334.

When did AMIGO J-9 receive FDA 510(k) clearance?

AMIGO J-9 received FDA 510(k) clearance on 1994-05-18, under 510(k) number K940334.

Who is the listed applicant for AMIGO J-9?

The FDA 510(k) record lists Amigo Mobility Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMIGO J-9?

The FDA product code for AMIGO J-9 is INI.

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Other records listing Amigo Mobility Intl., 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.

K101507AMIGO CLASSIC FDK092936AMIGO ESCORT 7.5, MODEL 760001 PHSK010503AMIGO WHEELCHAIRK992619AMIGO MODEL 680000 (AMIGO EXCITE F 350)K983987AMIGO MODEL 590000K981121AMIGO RT

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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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