510(k) · Cleared
ClearedMBATH 1000 (60)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enneking Medical, Inc. · ILJ Bath, Hydro-Massage
Cleared on Jan 26, 2006 after a 139-day review. The FDA summary names no predicate by number.
- Decided
- Jan 26, 2006
- Review
- 139 days
- Class
- Class II
- Product code
- ILJ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ILJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All ILJ devicesILJ Bath, Hydro-Massage: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILJ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · ILJ
Too few ILJ 510(k)s in any year since 2007 to give a median.
Recalls per year · ILJ
No recall names ILJ since 2007.
Adverse event reports per year · ILJ
11in 2025
MAUDE reports naming product code ILJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 1 | — | 0 | 22 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 1 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 85 |
| 2013 | 0 | — | 0 | 210 |
| 2014 | 0 | — | 0 | 188 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 57 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EMI mBath and eBath is a Product that consists of water agitators and a tub that is filled with water. It is used in the bathing of an individual, by an attendant, in either a commercial or residential setting. The eBath uses a microprocessor to control water filling The temperature monitoring, while the mBath uses manual gages. Product is equipped with an integrated AC powered hydraulic lift transport chair in which the attendant can use to assist an individual into the bath. The Product is available in both 60" and 70" lengths along with an optional door and weight scale.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052479: MBATH 1000 (60).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052479
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026