FDA 510(k)

ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER

K-Number: K113544 · 2012-07-27

Decision Date2012-07-27

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Prospera Corporation. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K113544. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER?

ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Prospera Corporation. The 510(k) number is K113544.

When did ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER receive FDA 510(k) clearance?

ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER received FDA 510(k) clearance on 2012-07-27, under 510(k) number K113544.

Who is the listed applicant for ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER?

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

What is the FDA product code for ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER?

The FDA product code for ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER is GZJ.

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Other records listing Prospera Corporation as applicant

K122744PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER

Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.