510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201239Substantially Equivalent

NuEra Tight Family, EMS Model

Bios S.r.l., Vimodrone, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201239 is the FDA 510(k) clearance record for NuEra Tight Family, EMS Model, a class II device, cleared for Bios S.R.L. on under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning). FDA's definition for product code NGX reads: "A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties...". FDA records list 11 510(k) clearances for Bios S.R.L., from to . As of , FDA records show no recalls naming K201239.

Clearance record

Decision date
Received
(238 days to decision)
Product code
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Bios S.R.L. Via Guido Rossa 10/12, Vimodrone, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGX

Trailing 12 months
6 clearances under product code NGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NGX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260