# K223729: FLOWpresso

- Pathway: 510(k) (Traditional)
- Applicant: Medella Health Limited
- Decided: Dec 21, 2023 after 373 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K881632 (1988). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193550: Therm-X, Zenith Technical Innovations (2020) Summary page 5.

## Most influential descendants
- K232965: Leg Massager (Models:RP-ALM070H, RP-ALM071H) (2024), 2 descendants of its own
- K254200: Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) (2026), 0 descendants of its own
- K251662: Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) (2025), 0 descendants of its own

## Indications for use
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat post traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy are indicated. Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.

Source page: https://510kreport.com/device/K223729
Methodology: https://510kreport.com/methodology