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FDA 510(k)

CLASSIC TENS

K-Number: K020437 · 2002-03-15

ApplicantCare Rehab, Inc.
Decision Date2002-03-15
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CLASSIC TENS is the device name listed in this FDA 510(k) record. The listed applicant is Care Rehab, Inc.. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K020437. 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 CLASSIC TENS?

CLASSIC TENS is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Care Rehab, Inc.. The 510(k) number is K020437.

When did CLASSIC TENS receive FDA 510(k) clearance?

CLASSIC TENS received FDA 510(k) clearance on 2002-03-15, under 510(k) number K020437.

Who is the listed applicant for CLASSIC TENS?

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

What is the FDA product code for CLASSIC TENS?

The FDA product code for CLASSIC TENS 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.

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Other records listing Care Rehab, 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.

K021905CLASSIC NMSK020516CARE IFC PLUSK984025CARE TENS

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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