# K162010: HPM-6000U

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Dec 13, 2016 after 146 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K891773 (1989). 10 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973096: Neotonus Model 1000 Muscle Stimulator System, Neotonus, Inc. (1998) Summary page 4.

## Most influential descendants
- K181497: HPM-6000UF (2018), 6 descendants of its own
- K262353: BTL-299-F (2026), 0 descendants of its own
- K252334: PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) (2026), 0 descendants of its own
- K251026: Regenesis EMS Chair (2025), 0 descendants of its own
- K241516: BTL-398 (2025), 0 descendants of its own

## Indications for use
HPM-6000U is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

Source page: https://510kreport.com/device/K162010
Methodology: https://510kreport.com/methodology