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FDA 510(k)

PELVEX HOMETRAINER

K-Number: K002043 · 2001-05-21

ApplicantPurdue Technology Park
Decision Date2001-05-21
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PELVEX HOMETRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Purdue Technology Park. It received FDA 510(k) clearance on 2001-05-21 under 510(k) number K002043. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELVEX HOMETRAINER?

PELVEX HOMETRAINER is a medical device that received FDA 510(k) clearance on 2001-05-21. The listed applicant is Purdue Technology Park. The 510(k) number is K002043.

When did PELVEX HOMETRAINER receive FDA 510(k) clearance?

PELVEX HOMETRAINER received FDA 510(k) clearance on 2001-05-21, under 510(k) number K002043.

Who is the listed applicant for PELVEX HOMETRAINER?

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

What is the FDA product code for PELVEX HOMETRAINER?

The FDA product code for PELVEX HOMETRAINER is HIR.

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Related Devices (Code: HIR)

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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