# K160992: HPM-6000

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Oct 21, 2016 after 196 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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: 1 generation back to K952089 (1995). 2 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973929: Neotonus MS-101 Magnetic Muscle Stimulator System, Neotonus, Inc. (1998) Summary page 5.
- K952089: Rich-Mar CM-II Combined Muscle Stimulator, Interferential, Tens & Therapeutic Ultrasound Device, Rich-Mar Corp. (1995) Summary page 9.

## Most influential descendants
- K190456: BTL 799-2L (2019), 11 descendants of its own
- K203710: Storz Medical MAGNETOLITH Muscle Stimulator (2021), 4 descendants of its own
- K200382: BTL-703-2 (2021), 4 descendants of its own
- K203488: emField (2021), 3 descendants of its own
- K240234: BTL-899MS (2024), 2 descendants of its own

## Indications for use
The HPM-6000 device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. Indications for Use for Muscle Stimulators: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis • Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K160992
Methodology: https://510kreport.com/methodology