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FDA 510(k)

NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES

K-Number: K021165 · 2002-07-01

ApplicantBromac Assistive Technology
Decision Date2002-07-01
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Bromac Assistive Technology. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K021165. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES?

NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Bromac Assistive Technology. The 510(k) number is K021165.

When did NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES receive FDA 510(k) clearance?

NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES received FDA 510(k) clearance on 2002-07-01, under 510(k) number K021165.

Who is the listed applicant for NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES?

The FDA 510(k) record lists Bromac Assistive Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES?

The FDA product code for NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES is IPL.

Related Clinical Trials

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Other records listing Bromac Assistive Technology 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.

K012345NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

Related Devices (Code: IPL)

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.

K243783Walking rehabilitation training electric wheelchair (ZW518)Shenzhen Zuowei Technology Co., Ltd.K202728Action Trackchair HawkAction Manufacturing, Inc.K203761ParaMotionPowerbasetec GmbHK191334Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08Matia Robotics (Us), Inc.K190682Explorer MiniPermobil ABK191874F5 Corpus VSPermobil AB

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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