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FDA 510(k)

TENSCARE ITOUCH MODEL(S) EASY AND PLUS

K-Number: K082377 · 2009-02-09

ApplicantTenscare, Ltd.
Decision Date2009-02-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENSCARE ITOUCH MODEL(S) EASY AND PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2009-02-09 under 510(k) number K082377. 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 TENSCARE ITOUCH MODEL(S) EASY AND PLUS?

TENSCARE ITOUCH MODEL(S) EASY AND PLUS is a medical device that received FDA 510(k) clearance on 2009-02-09. The listed applicant is Tenscare, Ltd.. The 510(k) number is K082377.

When did TENSCARE ITOUCH MODEL(S) EASY AND PLUS receive FDA 510(k) clearance?

TENSCARE ITOUCH MODEL(S) EASY AND PLUS received FDA 510(k) clearance on 2009-02-09, under 510(k) number K082377.

Who is the listed applicant for TENSCARE ITOUCH MODEL(S) EASY AND PLUS?

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

What is the FDA product code for TENSCARE ITOUCH MODEL(S) EASY AND PLUS?

The FDA product code for TENSCARE ITOUCH MODEL(S) EASY AND PLUS is GZJ.

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Other records listing Tenscare, Ltd. as applicant

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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

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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