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Dermatek 4000

by Anacom General Corp.

510(k) K911057

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911057 Date5 Apr 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
INX
Device Class
Class II
Regulation
21 CFR Part 890.5160
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Dermatek 4000 is an Air Fluidized Bed, classified as a device with a device class of 2. It is used in the field of Physical Medicine.

The Dermatek 4000 is supplied with the specification that it is substantially equivalent, with a clearance type of Traditional and an FDA 510K authorization. The device has a product code of INX and is registered with the FDA under several registration numbers, including 3014650138, 3007420694, 1824206, 3018070887, 9611484, and 3005529226.

Questions

AI-generated answers, 6 Oct 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 Dermatek 4000 used for?

    The Dermatek 4000 is an air fluidized bed used in the field of physical medicine, as indicated by its device classification and FDA registration under medical specialty description Physical Medicine.

  • How is the Dermatek 4000 supplied and authorized?

    The Dermatek 4000 is supplied as substantially equivalent under a traditional FDA 510(k) clearance (K911057) with product code INX, based on its authorization data showing decision description Substantially Equivalent and clearance type Traditional.

  • What regulatory identifiers are associated with the Dermatek 4000?

    The Dermatek 4000 is registered with the FDA under multiple registration numbers including 3014650138, 3007420694, 1824206, 3018070887, 9611484, and 3005529226, and is listed under device class 2 with product code INX and regulation number 890.5160.