# K201239: NuEra Tight Family, EMS Model

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Dec 31, 2020 after 238 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010335 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190456: BTL 799-2L, BTL Industries, Inc. (2019) Summary page 4.

## Indications for use
The NuEra Tight Family, EMS Model, is intended for: - improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; - strengthening, toning and firming of buttocks, thighs and calves; - improvement of muscle tone and firmness, for strengthening muscles in arms.

Source page: https://510kreport.com/device/K201239
Methodology: https://510kreport.com/methodology