PATIENT TURNING AND REPOSITIONING G DEV.— 510(k) K770499

Name: FDA 510(k) clearance K770499
Creator: U.S. Food and Drug Administration
Published: 1977-04-29

Substantially Equivalent

Patient Healthguards Corp.

FDA 510(k) clearance K770499 for PATIENT TURNING AND REPOSITIONING G DEV., Substantially Equivalent on 1977-04-29. Applicant: Patient Healthguards Corp.. Device class: 1.

Clearance details

Applicant: Patient Healthguards Corp.
Product code: Code FMR
Device class: Class 1
Regulation: 21 CFR 880.6785
Advisory panel: General Hospital
Date received: 1977-03-14
Decision date: 1977-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMR

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K871475 — SOLOLIFT - PATIENT TRANSFER STRETCHER1987-05-11
K801796 — THE COMFORT LIFT1980-08-13
K800373 — TENDERLIFT1980-03-12
K792318 — SKIL-CARE TURN AND HOLD PAD1979-12-20

Adverse events under product code FMR

product code FMR

Other: 1
Total: 1

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.