# K992099: Bio Spa Intelligent

- Pathway: 510(k) (Traditional)
- Applicant: Starbene
- Decided: Jan 18, 2002 after 942 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES : 1- Relaxation of Muscle Spasm 2- Prevention or retardation of disuse atrophy 3- Increasing local blood circulation 4- Muscle re-education 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and 6- Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K992099
Methodology: https://510kreport.com/methodology