# K240234: BTL-899MS

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Aug 17, 2024 after 201 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: 9 generations back to K010335 (2001). 46 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203488: emField, Zimmer Medizinsysteme GmbH (2021) Summary page 5.
- K200382: BTL-703-2, Btl (2021) Summary page 5.
- K203710: Storz Medical MAGNETOLITH Muscle Stimulator, Storz Medical AG (2021) Summary page 5.

## Most influential descendants
- K253408: CoolTone (2026), 0 descendants of its own
- K251594: truFlex (2025), 0 descendants of its own

## Indications for use
BTL-899MS is indicated to be used 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. The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The BTL-899MS 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/K240234
Methodology: https://510kreport.com/methodology