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FDA 510(k)

NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

K-Number: K012345 · 2001-10-03

ApplicantBromac Assistive Technology
Decision Date2001-10-03
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR 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 2001-10-03 under 510(k) number K012345. 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 MANUAL WHEELCHAIR?

NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Bromac Assistive Technology. The 510(k) number is K012345.

When did NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR receive FDA 510(k) clearance?

NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR received FDA 510(k) clearance on 2001-10-03, under 510(k) number K012345.

Who is the listed applicant for NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR?

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 MANUAL WHEELCHAIR?

The FDA product code for NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR is IPL.

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 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.

K021165NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES

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.

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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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