Prom Naid
510(k) K843581
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843581 | Date11 Dec 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Questions
AI-generated answers, 25 Sep 2026
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.