Model 804 TENS
by Oriental Medical Supplies, Inc.
510(k) K853442
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853442 | Date9 Dec 1985 | 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- Withdrawn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
- GZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Model 804 is a transcutaneous electrical nerve stimulator (TENS) designed to provide electrical stimulation. This device is used to deliver therapeutic pulses to assist in the management of pain.
This device is identified by K-number K853442 and has received FDA 510(k) clearance. It is a two-channel unit that features adjustable pulse width, pulse rate, and a treatment timer.
Other devices from Oriental Medical Supplies, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the Model 804?
The Model 804 is a transcutaneous electrical nerve stimulator (TENS) designed to deliver therapeutic electrical pulses to assist in the management of pain.
What features are available for adjusting the stimulation?
This device is a two-channel unit that provides users with the ability to adjust the pulse width, pulse rate, and treatment timer to suit specific therapeutic needs.
What is the regulatory status of this device?
The Model 804 has received FDA 510(k) clearance, identified by K-number K853442, following a determination of substantial equivalence.