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FDA 510(k)

MODEL ES-130

K-Number: K081943 · 2008-11-24

ApplicantIto Co., Ltd.
Decision Date2008-11-24
Product CodeBWK
DecisionSubstantially Equivalent

Device Summary

MODEL ES-130 is the device name listed in this FDA 510(k) record. The listed applicant is Ito Co., Ltd.. It received FDA 510(k) clearance on 2008-11-24 under 510(k) number K081943. The device is classified under product code BWK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL ES-130?

MODEL ES-130 is a medical device that received FDA 510(k) clearance on 2008-11-24. The listed applicant is Ito Co., Ltd.. The 510(k) number is K081943.

When did MODEL ES-130 receive FDA 510(k) clearance?

MODEL ES-130 received FDA 510(k) clearance on 2008-11-24, under 510(k) number K081943.

Who is the listed applicant for MODEL ES-130?

The FDA 510(k) record lists Ito Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL ES-130?

The FDA product code for MODEL ES-130 is BWK.

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Other records listing Ito Co., 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.

K203525D functionK112520US-101L, US-103SK081247TM-400K032793US-100 PORTABLE ULTRASOUND THERAPY UNITK022846SW-180 SHORTWAVE THERAPY UNITK990787TRIO 300

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Related Devices (Code: BWK)

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.

K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)Wuxi Jiajian Medical Instrument Co., Ltd.K220153Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd.K202861Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd.K200636AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc.K170391ANSiStim-PPDyansys, Inc.K152571StivaxBiegler GmbH

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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