SETMA VHT— 510(k) K853163

Name: FDA 510(k) clearance K853163
Creator: U.S. Food and Drug Administration
Published: 1985-11-05

Substantially Equivalent

Setma, Inc.

FDA 510(k) clearance K853163 for SETMA VHT, Substantially Equivalent on 1985-11-05. Applicant: Setma, Inc.. Device class: 2.

Clearance details

Applicant: Setma, Inc.
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
Advisory panel: Physical Medicine
Date received: 1985-07-30
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitehouse, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILJ

view all

K110994 — PARKER 5002011-07-06
K082951 — IMMERSION HYDROBATH2009-04-08
K052479 — MBATH 1000 (60)2006-01-26
K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM2004-04-05
K012057 — CASCADE BATH, MODEL 69002001-07-19

More clearances from Setma, Inc.

view all

K854861 — SETMA HYGIA BATH MODEL ST 72001986-01-03
K854263 — SETMA FHT, MODEL ST 81301985-11-13
K841397 — BURN BATH1984-05-18
K841395 — SHOWER TROLLEY1984-05-07
K841396 — TRANSFER TROLLEY1984-05-07

Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.