Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PainShield MD PLUS

K-Number: K221210 · 2022-11-23

ApplicantNanovibronix, Inc.
Decision Date2022-11-23
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PainShield MD PLUS is a medical device manufactured by Nanovibronix, Inc.. It received FDA 510(k) clearance on 2022-11-23 under approval 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. It is manufactured by Nanovibronix, Inc.. The 510(k) number is K221210.

When was PainShield MD PLUS approved by the FDA?

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

What company makes PainShield MD PLUS?

PainShield MD PLUS is manufactured by Nanovibronix, Inc..

What is the FDA product code for PainShield MD PLUS?

The FDA product code for PainShield MD PLUS is PFW.

Related Devices (Code: PFW)

K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC

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.

↑