# K253478: Motive™ Muscle Stimulator for Lower Back (OT01-1003)

- Pathway: 510(k) (Traditional)
- Applicant: Motive Health, Inc.
- Decided: Nov 6, 2025 after 23 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: 5 generations back to K940301 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150078: PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application), Smartmissimo Technologies Pte, Ltd. (2015) Summary page 13.

## Indications for use
The Motive™ Muscle Stimulator for Lower Back is intended for the stimulation of healthy muscles to improve or facilitate muscle performance. The Motive™ Muscle Stimulator for Lower Back is not intended to be used in conjunction with therapy or treat diseases or medical conditions of any kind. The Motive™ Muscle Stimulator for Lower Back device is indicated for adults of 22 years of age and older.

Source page: https://510kreport.com/device/K253478
Methodology: https://510kreport.com/methodology