ECU 1218 Environmental Control System
510(k) K840808
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840808 | Date19 Mar 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- Withdrawn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
- Full name
- Ecu 1218
- 510(k) Number
- FDA Product Code
- IQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3725
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ECU 1218 is a Powered Environmental Control System, designed to assist individuals with limited mobility in operating television sets. Classified under FDA product code IQA and regulation number 890.3725, this device facilitates adaptive access to television viewing by enabling control through alternative input methods, supporting physical medicine applications.
This device is supplied as a reusable Class II medical product, cleared under FDA 510(k) submission K840808 with a Substantially Equivalent determination by the Physical Medicine Advisory Committee. It is intended for use in clinical and home settings, with no specified sterility requirements. The system’s regulatory classification and clearance date (March 19, 1984) reflect its compliance with U.S. medical device standards for assistive technology.