FDA 510(k)

CARE TENS

K-Number: K984025 · 1999-02-10

Decision Date1999-02-10

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CARE 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 1999-02-10 under 510(k) number K984025. 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 CARE TENS?

CARE TENS is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is Care Rehab, Inc.. The 510(k) number is K984025.

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

CARE TENS received FDA 510(k) clearance on 1999-02-10, under 510(k) number K984025.

Who is the listed applicant for CARE 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 CARE TENS?

The FDA product code for CARE TENS is GZJ.

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 NMS K020516CARE IFC PLUS K020437CLASSIC TENS

Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical 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.