PMHHumanitarian device exemption

Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)

Unknown

PMH is the FDA product code for Mechanical Compression Device Fecal Incontinence (Non-Manually Operated). FDA's definition for this code reads: "For treatment of fecal incontinence in patients who have failed conservative therapies". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PMH
Device name: Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)
FDA definition: For treatment of fecal incontinence in patients who have failed conservative therapies
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Torax Medical, Inc.

Recent clearances

Product code PMH

FDA records hold no clearances under product code PMH.

Recent recalls

Product code PMH

FDA records show no recalls under product code PMH.

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)