MedtechSourcebook

HELTON INC

Contract manufacturer ยท Morrison, TN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3004860474 (openFDA record; or search FDA's registration database)
FEI number
3004860474
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Helton Inc (FDA owner/operator no. 10087957)
Registered address
8700 Manchester Hwy, Morrison, TN 37357
Contract listings
1 device listings, 1 product codes, first listed May 5, 2023
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
FNJBed, ManualClass IGeneral hospitalContract manufacturingMay 5, 2023