Stim-Ex 201
510(k) K800486
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800486 | Date19 Mar 1980 | 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- Withdrawn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
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Stim-Ex 201 is a medical device designed for use in physical medicine. It functions as an electrical stimulation system intended to provide therapeutic benefits to patients.
This device is supplied under FDA 510(k) clearance K800486. It is manufactured by Th Charters, Inc. and was determined to be substantially equivalent to existing devices.
Other devices from Th Charters, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the primary function of the Stim-Ex 201?
The Stim-Ex 201 is an electrical stimulation system engineered for use in physical medicine. It is intended to provide therapeutic benefits to patients through controlled electrical stimulation.
What is the regulatory status of this device?
The Stim-Ex 201 is supplied under FDA 510(k) clearance K800486. It was determined to be substantially equivalent to existing devices in the physical medicine category following a traditional review process.
Who is the manufacturer of the Stim-Ex 201?
The Stim-Ex 201 is manufactured by Th Charters, Inc., located in McHenry, Illinois.