FDA 510(k)

PainShield MD PLUS

K-Number: K221210 · 2022-11-23

Decision Date2022-11-23

Product CodePFW

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PainShield MD PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Nanovibronix, Inc.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K221210. The device is classified under product code PFW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PainShield MD PLUS?

PainShield MD PLUS is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Nanovibronix, Inc.. The 510(k) number is K221210.

When did PainShield MD PLUS receive FDA 510(k) clearance?

PainShield MD PLUS received FDA 510(k) clearance on 2022-11-23, under 510(k) number K221210.

Who is the listed applicant for PainShield MD PLUS?

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 PainShield MD PLUS?

The FDA product code for PainShield MD PLUS is PFW.

Related Devices (Code: PFW)

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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Official Source

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