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FDA 510(k)

ACULIFE, MODEL SMW-01

K-Number: K051197 · 2006-03-28

ApplicantInno-Health Technology, Inc.
Decision Date2006-03-28
Product CodeBWK
DecisionSubstantially Equivalent

Device Summary

ACULIFE, MODEL SMW-01 is the device name listed in this FDA 510(k) record. The listed applicant is Inno-Health Technology, Inc.. It received FDA 510(k) clearance on 2006-03-28 under 510(k) number K051197. The device is classified under product code BWK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACULIFE, MODEL SMW-01?

ACULIFE, MODEL SMW-01 is a medical device that received FDA 510(k) clearance on 2006-03-28. The listed applicant is Inno-Health Technology, Inc.. The 510(k) number is K051197.

When did ACULIFE, MODEL SMW-01 receive FDA 510(k) clearance?

ACULIFE, MODEL SMW-01 received FDA 510(k) clearance on 2006-03-28, under 510(k) number K051197.

Who is the listed applicant for ACULIFE, MODEL SMW-01?

The FDA 510(k) record lists Inno-Health Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACULIFE, MODEL SMW-01?

The FDA product code for ACULIFE, MODEL SMW-01 is BWK.

Related Clinical Trials

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.

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Other records listing Inno-Health Technology, 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.

K091933ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01

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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