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FDA 510(k)

POTENS +

K-Number: K033137 · 2003-12-08

ApplicantWada, Inc.
Decision Date2003-12-08
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POTENS + is the device name listed in this FDA 510(k) record. The listed applicant is Wada, Inc.. It received FDA 510(k) clearance on 2003-12-08 under 510(k) number K033137. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTENS +?

POTENS + is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is Wada, Inc.. The 510(k) number is K033137.

When did POTENS + receive FDA 510(k) clearance?

POTENS + received FDA 510(k) clearance on 2003-12-08, under 510(k) number K033137.

Who is the listed applicant for POTENS +?

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

What is the FDA product code for POTENS +?

The FDA product code for POTENS + is JPA.

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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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