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FDA 510(k)

AC WOUND TREATMENT SYSTEM

K-Number: K111949 · 2012-06-29

ApplicantNanovibronix, Inc.
Decision Date2012-06-29
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AC WOUND TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nanovibronix, Inc.. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K111949. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AC WOUND TREATMENT SYSTEM?

AC WOUND TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Nanovibronix, Inc.. The 510(k) number is K111949.

When did AC WOUND TREATMENT SYSTEM receive FDA 510(k) clearance?

AC WOUND TREATMENT SYSTEM received FDA 510(k) clearance on 2012-06-29, under 510(k) number K111949.

Who is the listed applicant for AC WOUND TREATMENT SYSTEM?

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

What is the FDA product code for AC WOUND TREATMENT SYSTEM?

The FDA product code for AC WOUND TREATMENT SYSTEM is OMP.

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 Nanovibronix, 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.

K221210PainShield MD PLUS

Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

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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