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FDA 510(k)

804SIII; 804W; LIBRA TENS; 410; S-TENS II

K-Number: K021846 · 2002-11-22

ApplicantBody Clock Health Care, Ltd.
Decision Date2002-11-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

804SIII; 804W; LIBRA TENS; 410; S-TENS II is the device name listed in this FDA 510(k) record. The listed applicant is Body Clock Health Care, Ltd.. It received FDA 510(k) clearance on 2002-11-22 under 510(k) number K021846. 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 804SIII; 804W; LIBRA TENS; 410; S-TENS II?

804SIII; 804W; LIBRA TENS; 410; S-TENS II is a medical device that received FDA 510(k) clearance on 2002-11-22. The listed applicant is Body Clock Health Care, Ltd.. The 510(k) number is K021846.

When did 804SIII; 804W; LIBRA TENS; 410; S-TENS II receive FDA 510(k) clearance?

804SIII; 804W; LIBRA TENS; 410; S-TENS II received FDA 510(k) clearance on 2002-11-22, under 510(k) number K021846.

Who is the listed applicant for 804SIII; 804W; LIBRA TENS; 410; S-TENS II?

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

What is the FDA product code for 804SIII; 804W; LIBRA TENS; 410; S-TENS II?

The FDA product code for 804SIII; 804W; LIBRA TENS; 410; S-TENS II is GZJ.

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Other records listing Body Clock Health Care, Ltd. 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.

K091045SMART TENS, MODEL: D-BC05TK041359BODY CLOCK STIMPLUS AND STIMPLUS PROK022849BODY CLOCK TENS N' TONEK022731V TENS PLUSK022493EMS 400K022076FIRST CHOICE & FIRST CHOICE PLUS

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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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