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FDA 510(k)

PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT

K-Number: K011017 · 2001-09-24

ApplicantRehabilicare, Inc.
Decision Date2001-09-24
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT is the device name listed in this FDA 510(k) record. The listed applicant is Rehabilicare, Inc.. It received FDA 510(k) clearance on 2001-09-24 under 510(k) number K011017. 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 PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT?

PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT is a medical device that received FDA 510(k) clearance on 2001-09-24. The listed applicant is Rehabilicare, Inc.. The 510(k) number is K011017.

When did PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT receive FDA 510(k) clearance?

PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT received FDA 510(k) clearance on 2001-09-24, under 510(k) number K011017.

Who is the listed applicant for PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT?

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

What is the FDA product code for PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT?

The FDA product code for PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT is GZJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rehabilicare, 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.

K022405MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MICK982410SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICEK971542ORTHO DX NEUROMUSCULAR STIMULATOR

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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