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FDA 510(k)

TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM

K-Number: K010011 · 2001-01-12

ApplicantAccelerated Rehab Designs, Inc.
Decision Date2001-01-12
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Rehab Designs, Inc.. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K010011. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM?

TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Accelerated Rehab Designs, Inc.. The 510(k) number is K010011.

When did TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM receive FDA 510(k) clearance?

TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM received FDA 510(k) clearance on 2001-01-12, under 510(k) number K010011.

Who is the listed applicant for TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM?

The FDA 510(k) record lists Accelerated Rehab Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM?

The FDA product code for TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM is ITI.

Related Clinical Trials

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Other records listing Accelerated Rehab Designs, 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.

K012281TRS-2000 POWER TILT/POWER RECLINE SYSTEMK992804T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCERK992828E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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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