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Prom Naid

by Lossing Orthopedic, Inc.

510(k) K843581

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 NumberK843581 Date11 Dec 1984ClearedStatusActive

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  • Withdrawn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
ITH
Device Class
Class II
Regulation
21 CFR Part 890.5900
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Prom Naid is Equipment, Traction, Powered, classified as a class 2 device. It is substantially equivalent to other devices and has a product code of ITH.

The Prom Naid is supplied by Lossing Orthopedic, Inc. and has FDA 510K authorizations. It has a regulation number of 890.5900 and is used in the field of Physical Medicine. The device has a specific k number, K843581, and is registered with the FDA.

Other devices from Lossing Orthopedic, Inc.

See all devices from Lossing Orthopedic, Inc. →

Questions

AI-generated answers, 25 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 Prom Naid used for?

    The Prom Naid is used in the field of Physical Medicine, specifically for traction purposes, as classified under the product code ITH.

  • Is the Prom Naid a single-use device?

    The device data does not specify whether the Prom Naid is for single-use or reuse, but it is classified as a class 2 device with a specific regulation number of 890.5900.

  • What are the regulatory authorizations for the Prom Naid?

    The Prom Naid has FDA 510K authorizations, with a k number of K843581, indicating its substantial equivalence to other devices.

  • Who is the manufacturer of the Prom Naid?

    The Prom Naid is supplied by Lossing Orthopedic, Inc., with a contact person of SUSAN G WOLF, based in Minneapolis, MN.