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FDA 510(k)

EMS 400

K-Number: K022493 · 2002-10-11

ApplicantBody Clock Health Care, Ltd.
Decision Date2002-10-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMS 400 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 2002-10-11 under 510(k) number K022493. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS 400?

EMS 400 is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Body Clock Health Care, Ltd.. The 510(k) number is K022493.

When did EMS 400 receive FDA 510(k) clearance?

EMS 400 received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022493.

Who is the listed applicant for EMS 400?

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 EMS 400?

The FDA product code for EMS 400 is IPF.

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' TONEK021846804SIII; 804W; LIBRA TENS; 410; S-TENS IIK022731V TENS PLUSK022076FIRST CHOICE & FIRST CHOICE PLUS

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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