FDA 510(k)

PLS MINI

K-Number: K792501 · 1980-02-26

Decision Date1980-02-26

Product CodeBWJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PLS MINI is the device name listed in this FDA 510(k) record. The listed applicant is Staodynamics, Inc.. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K792501. The device is classified under product code BWJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLS MINI?

PLS MINI is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Staodynamics, Inc.. The 510(k) number is K792501.

When did PLS MINI receive FDA 510(k) clearance?

PLS MINI received FDA 510(k) clearance on 1980-02-26, under 510(k) number K792501.

Who is the listed applicant for PLS MINI?

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

What is the FDA product code for PLS MINI?

The FDA product code for PLS MINI is BWJ.

Other records listing Staodynamics, Inc. as applicant

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.

K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENS K843964TENS-AID PREMIUM ELECTRODES K832988STAODYN EMS/PLUS K81328310D (TENS DEVICE)K813098TENS DEVICE K811345INSIGHT

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Related Devices (Code: BWJ)

K792529POINT LOCATOR STIMULATORStaodynamics, Inc.K772424RYUSEIErcona Corp.

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.