PAINSHIELD MD— 510(k) K081075

Substantially Equivalent

Nano Vibronix , Ltd.

FDA 510(k) clearance K081075 for PAINSHIELD MD, Substantially Equivalent on 2008-08-22. Applicant: Nano Vibronix , Ltd.. Device class: 2.

Clearance details

Applicant: Nano Vibronix , Ltd.
Product code: Code PFW
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2008-04-16
Decision date: 2008-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PFW

K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device2026-04-28
K233210 — sam CS Long Duration Ultrasound Device2023-10-25
K223019 — sam 2.0 Long Ultrasound Device2023-06-23
K221210 — PainShield MD PLUS2022-11-23
K211513 — sam X1 Long Duration Ultrasound Device2021-08-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.