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FDA 510(k)

UNIVERSAL POWER FLEX

K-Number: K851177 · 1985-06-28

ApplicantBiodynamic Technologies, Inc.
Decision Date1985-06-28
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL POWER FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamic Technologies, Inc.. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K851177. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL POWER FLEX?

UNIVERSAL POWER FLEX is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K851177.

When did UNIVERSAL POWER FLEX receive FDA 510(k) clearance?

UNIVERSAL POWER FLEX received FDA 510(k) clearance on 1985-06-28, under 510(k) number K851177.

Who is the listed applicant for UNIVERSAL POWER FLEX?

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

What is the FDA product code for UNIVERSAL POWER FLEX?

The FDA product code for UNIVERSAL POWER FLEX is BXB.

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Related Devices (Code: BXB)

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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