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FDA 510(k)

ULTIMA TENS XL-A1

K-Number: K020846 · 2002-05-21

ApplicantTenscare, Ltd.
Decision Date2002-05-21
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ULTIMA TENS XL-A1 is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2002-05-21 under 510(k) number K020846. 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 TENS XL-A1?

ULTIMA TENS XL-A1 is a medical device that received FDA 510(k) clearance on 2002-05-21. The listed applicant is Tenscare, Ltd.. The 510(k) number is K020846.

When did ULTIMA TENS XL-A1 receive FDA 510(k) clearance?

ULTIMA TENS XL-A1 received FDA 510(k) clearance on 2002-05-21, under 510(k) number K020846.

Who is the listed applicant for ULTIMA TENS XL-A1?

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 ULTIMA TENS XL-A1?

The FDA product code for ULTIMA TENS XL-A1 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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