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FDA 510(k)

XLT, REA COMFORT, SPIREA, ZOOM

K-Number: K943936 · 1994-09-21

ApplicantElectric Mobility Corp.
Decision Date1994-09-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

XLT, REA COMFORT, SPIREA, ZOOM is the device name listed in this FDA 510(k) record. The listed applicant is Electric Mobility Corp.. It received FDA 510(k) clearance on 1994-09-21 under 510(k) number K943936. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLT, REA COMFORT, SPIREA, ZOOM?

XLT, REA COMFORT, SPIREA, ZOOM is a medical device that received FDA 510(k) clearance on 1994-09-21. The listed applicant is Electric Mobility Corp.. The 510(k) number is K943936.

When did XLT, REA COMFORT, SPIREA, ZOOM receive FDA 510(k) clearance?

XLT, REA COMFORT, SPIREA, ZOOM received FDA 510(k) clearance on 1994-09-21, under 510(k) number K943936.

Who is the listed applicant for XLT, REA COMFORT, SPIREA, ZOOM?

The FDA 510(k) record lists Electric Mobility Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XLT, REA COMFORT, SPIREA, ZOOM?

The FDA product code for XLT, REA COMFORT, SPIREA, ZOOM is IOR.

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Related Devices (Code: IOR)

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

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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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