# K040905: Wellness/Jolivete

- Pathway: 510(k) (Traditional)
- Applicant: Tohkai Precision Ind., Ltd.
- Decided: Feb 23, 2005 after 322 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
No predicates in its family tree.
55 later devices descend from it; 1 cites it directly.
0 of 56 devices 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.

## Most influential descendants
- K092435: Verseo Air Pressure Massager (2010), 54 descendants of its own
- K122154: Powerplay Muscle Massager (2012), 53 descendants of its own
- K160608: NormaTec Pulse and NormaTec Pulse Pro (2016), 51 descendants of its own
- K182668: Rapid Reboot Compression Therapy System (2018), 38 descendants of its own
- K193354: Air Compression Therapy Device (2020), 20 descendants of its own

## Indications for use
By individuals or clinicians, to provide temporary relief from localized aches, pains and/or swelling of feet, ankles or calves caused by poor circulation, muscular stress or edema. May also be used to temporarily relieve symptoms of lymphoedema.

Source page: https://510kreport.com/device/K040905
Methodology: https://510kreport.com/methodology