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FDA 510(k)

PFLEX EM(TM) (EXERCISE MONITOR)

K-Number: K864719 · 1987-03-16

ApplicantHealth Products, Inc.
Decision Date1987-03-16
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PFLEX EM(TM) (EXERCISE MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Health Products, Inc.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K864719. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PFLEX EM(TM) (EXERCISE MONITOR)?

PFLEX EM(TM) (EXERCISE MONITOR) is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Health Products, Inc.. The 510(k) number is K864719.

When did PFLEX EM(TM) (EXERCISE MONITOR) receive FDA 510(k) clearance?

PFLEX EM(TM) (EXERCISE MONITOR) received FDA 510(k) clearance on 1987-03-16, under 510(k) number K864719.

Who is the listed applicant for PFLEX EM(TM) (EXERCISE MONITOR)?

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

What is the FDA product code for PFLEX EM(TM) (EXERCISE MONITOR)?

The FDA product code for PFLEX EM(TM) (EXERCISE MONITOR) is BWF.

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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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