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FDA 510(k)

MODEL PS-1 PENA MUSCLE STIMULATOR

K-Number: K980448 · 1998-04-03

ApplicantRadionics, Inc.
Decision Date1998-04-03
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL PS-1 PENA MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K980448. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL PS-1 PENA MUSCLE STIMULATOR?

MODEL PS-1 PENA MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Radionics, Inc.. The 510(k) number is K980448.

When did MODEL PS-1 PENA MUSCLE STIMULATOR receive FDA 510(k) clearance?

MODEL PS-1 PENA MUSCLE STIMULATOR received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980448.

Who is the listed applicant for MODEL PS-1 PENA MUSCLE STIMULATOR?

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

What is the FDA product code for MODEL PS-1 PENA MUSCLE STIMULATOR?

The FDA product code for MODEL PS-1 PENA MUSCLE STIMULATOR is IPF.

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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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