# K961426: Bio Boost

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Oct 28, 1996 after 199 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: 1 generation back to K915638 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915638: Talley TM200 Intermttent Compression Unit, Progressive Medical Technology, Inc. (1992) Summary page 1.

## Indications for use
Like other Powered Inflatable Tube Massagers, the Bio Boost™ provides intermittent compression therapy for control, management and treatment of lower limb conditions such as lymphedema of the lower limb, edema from sports injuries, and venous insufficiency. Devices providing intermittent compression therapy have been marketed for many years for these indications.

Source page: https://510kreport.com/device/K961426
Methodology: https://510kreport.com/methodology