# K232937: BTL-899M

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Dec 26, 2023 after 97 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: 2 generations back to K952089 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160992: HPM-6000, BTL Industries, Inc. (2016) Summary page 6.

## Indications for use
The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The BTL-899M 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/K232937
Methodology: https://510kreport.com/methodology