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FDA 510(k)

SUNSPEX TECHNOLOGIES MODEL SE 02

K-Number: K021371 · 2002-05-16

ApplicantSunpex Technology Co., Ltd.
Decision Date2002-05-16
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUNSPEX TECHNOLOGIES MODEL SE 02 is the device name listed in this FDA 510(k) record. The listed applicant is Sunpex Technology Co., Ltd.. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K021371. 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 SUNSPEX TECHNOLOGIES MODEL SE 02?

SUNSPEX TECHNOLOGIES MODEL SE 02 is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Sunpex Technology Co., Ltd.. The 510(k) number is K021371.

When did SUNSPEX TECHNOLOGIES MODEL SE 02 receive FDA 510(k) clearance?

SUNSPEX TECHNOLOGIES MODEL SE 02 received FDA 510(k) clearance on 2002-05-16, under 510(k) number K021371.

Who is the listed applicant for SUNSPEX TECHNOLOGIES MODEL SE 02?

The FDA 510(k) record lists Sunpex Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNSPEX TECHNOLOGIES MODEL SE 02?

The FDA product code for SUNSPEX TECHNOLOGIES MODEL SE 02 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 Sunpex Technology Co., Ltd. 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.

K033019SUNPEX TECHNOLOGIES MODEL SE03K024175SUNPEX TECHNOLOGIES MODEL PWK021925SUNPEX TECHNOLOGIES MODEL SE 01

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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