ILMClass II

Bath, Sitz, Powered

21 CFR 890.5100 / Physical Medicine

ILM is the FDA product code for Bath, Sitz, Powered, a class II device type, regulated under 21 CFR 890.5100. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1996-04-01, and no recalls.

Classification record

Product code: ILM
Device name: Bath, Sitz, Powered
Regulation: 21 CFR 890.5100
Device class: Class II
Review panel: Physical Medicine
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code ILM

By decision year

2 clearances under product code ILM with a decision year between 1982 and 1996, 1982 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ILM by decision year
Year	Clearances
1982	1
1996	1

Applicants with the most clearances

Product code ILM

Applicants holding the most 510(k) clearances under product code ILM
Applicant	Clearances
Keith Products, Inc.	1
Wall Manufacturer, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ILM.

Recent clearances

Product code ILM

Recent recalls

Product code ILM

FDA records show no recalls under product code ILM.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)