FDA 510(k)

BODY CLOCK TENS N' TONE

K-Number: K022849 · 2003-05-20

Decision Date2003-05-20

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BODY CLOCK TENS N' TONE 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 2003-05-20 under 510(k) number K022849. 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 BODY CLOCK TENS N' TONE?

BODY CLOCK TENS N' TONE is a medical device that received FDA 510(k) clearance on 2003-05-20. The listed applicant is Body Clock Health Care, Ltd.. The 510(k) number is K022849.

When did BODY CLOCK TENS N' TONE receive FDA 510(k) clearance?

BODY CLOCK TENS N' TONE received FDA 510(k) clearance on 2003-05-20, under 510(k) number K022849.

Who is the listed applicant for BODY CLOCK TENS N' TONE?

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 BODY CLOCK TENS N' TONE?

The FDA product code for BODY CLOCK TENS N' TONE is GZJ.

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Other records listing Body Clock Health Care, Ltd. as applicant

K091045SMART TENS, MODEL: D-BC05T K041359BODY CLOCK STIMPLUS AND STIMPLUS PRO K021846804SIII; 804W; LIBRA TENS; 410; S-TENS II K022731V TENS PLUS K022493EMS 400 K022076FIRST CHOICE & FIRST CHOICE PLUS

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.