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510(k) K770499

PATIENT TURNING AND REPOSITIONING G DEV. by Patient Healthguards Corp. — Product Code FMR

K770499 is an FDA 510(k) premarket notification submitted by Patient Healthguards Corp. for the device "PATIENT TURNING AND REPOSITIONING G DEV.". The FDA issued a decision of Substantially Equivalent on April 29, 1977. The device falls under product code FMR (Device, Transfer, Patient, Manual), a Class I device regulated under 21 CFR 880.6785.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1977
Date Received
March 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Transfer, Patient, Manual
Device Class
Class I
Regulation Number
880.6785
Review Panel
HO
Submission Type

Other clearances for product code FMR

  • K871475 — SOLOLIFT - PATIENT TRANSFER STRETCHER (May 11, 1987)
  • K801796 — THE COMFORT LIFT (August 13, 1980)
  • K800373 — TENDERLIFT (March 12, 1980)
  • K792318 — SKIL-CARE TURN AND HOLD PAD (December 20, 1979)

FDA data resources