# K080554: Inarex, Model 2D-LX

- Pathway: 510(k) (Traditional)
- Applicant: Inarex Corporation
- Decided: Aug 27, 2008 after 181 days
- Product code: JFB (Table, Physical Therapy, Multi Function)
- Device class: 2
- Regulation: 21 CFR 890.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K993461 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040031: Ceragem-C Thermal Acupressure Massager, Ceragem Co., Ltd. (2004) Summary page 1.
- K062476: Ceragem RH1 Automatic Thermal Massager, Ceragem International, Inc. (2006) Summary page 1.

## Most influential descendants
- K102281: Thermal Massage Bed, Model 2D-GX (2010), 0 descendants of its own

## Indications for use
Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and smoothing massage. Additionally, the thermal lamps provide topical heating for: * Temporary relief of minor muscle and joint pain, and stiffness * Temporary relief of minor joint pain associated with arthritis * Temporary increase in local circulation where applied * Relaxation of muscles:

Source page: https://510kreport.com/device/K080554
Methodology: https://510kreport.com/methodology