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The Lotecon Personal Care System

by Lotecon, Inc.

510(k) K950191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950191 Date12 Jun 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FNM
Device Class
Class II
Regulation
21 CFR Part 880.5550
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lotecon Personal Care System is a mattress, air flotation, alternating pressure device intended for general hospital use. It is classified as a Class II medical device under FDA regulation number 880.5550.

The device received FDA 510(k) clearance via traditional pathway under K950191 on June 12, 1995, and is substantially equivalent to a legally marketed device. It is manufactured by Lotecon, Inc. and assigned product code FNM.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Lotecon Personal Care System intended for?

    The Lotecon Personal Care System is intended for general hospital use as a mattress, air flotation, alternating pressure device to help prevent pressure ulcers by redistributing pressure through cyclic inflation and deflation of air cells.

  • How is the Lotecon Personal Care System supplied and is it reusable?

    The device is supplied as a reusable mattress system designed for repeated use in clinical settings; it is not labeled as single-use and requires proper cleaning and maintenance between patients according to manufacturer guidelines.

  • What regulatory pathway was used for the Lotecon Personal Care System?

    The Lotecon Personal Care System received FDA 510(k) clearance through the traditional pathway under submission K950191, demonstrating substantial equivalence to a legally marketed predicate device.