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New Support Sys. for Bedridden Patients

by Dase Co. 510(k)

Active United States

510(k) K821185

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821185 Date14 Sep 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FNL
Device Class
Class II
Regulation
21 CFR Part 880.5100
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent