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FDA 510(k)

ULTIMA FIVE

K-Number: K083494 · 2009-01-06

ApplicantPain Management Technologies
Decision Date2009-01-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTIMA FIVE is the device name listed in this FDA 510(k) record. The listed applicant is Pain Management Technologies. It received FDA 510(k) clearance on 2009-01-06 under 510(k) number K083494. 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 ULTIMA FIVE?

ULTIMA FIVE is a medical device that received FDA 510(k) clearance on 2009-01-06. The listed applicant is Pain Management Technologies. The 510(k) number is K083494.

When did ULTIMA FIVE receive FDA 510(k) clearance?

ULTIMA FIVE received FDA 510(k) clearance on 2009-01-06, under 510(k) number K083494.

Who is the listed applicant for ULTIMA FIVE?

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

What is the FDA product code for ULTIMA FIVE?

The FDA product code for ULTIMA FIVE is GZJ.

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Other records listing Pain Management Technologies 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.

K120054ULTIMA NEOK073386JOINT STIM, MODEL 1000K030375SOFT-TOUCH TENS ELECTRODEK011411SELF-ADHESIVE ELECTRODES

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical 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.

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