CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM— 510(k) K882092

Name: FDA 510(k) clearance K882092
Creator: U.S. Food and Drug Administration
Published: 1988-07-13

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K882092 for CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM, Substantially Equivalent on 1988-07-13. Applicant: Gaymar Industries, Inc.. Device class: 2.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1988-05-19
Decision date: 1988-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FNM

view all

K973169 — PRESSURE GUARD SITE SELECT (A)1998-02-20
K972022 — ZAK-20001998-01-22
K974319 — MIGHTY AIR1998-01-22
K974070 — PHYSIO/10001998-01-06
K972549 — SIMPULSE1997-11-18

More clearances from Gaymar Industries, Inc.

view all

K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA79002011-01-20
K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP2008-05-08
K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM1997-04-30
K963067 — SOF. PRESS EPC 51 SYSTEM1997-01-28
K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL2121996-08-09

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.