Electrical Neuro-muscular Stimulator
by Richards Medical Co., Inc. 510(k)
Active
510(k) K840895
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840895 | Date24 Apr 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 6 Oct 2026
The Electrical Neuro-muscular Stimulator is a device that delivers electrical impulses to stimulate nerves and muscles. It is used for therapeutic purposes in physical medicine applications.
This device is manufactured by Richards Medical Co., Inc. and is supplied as a single-use or reusable product. It has FDA 510(k) clearance with product code IPF and model number K840895, authorized on April 24, 1984.
Other devices from Richards Medical Co., Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Electrical Neuro-muscular Stimulator used for?
The Electrical Neuro-muscular Stimulator is a device that delivers electrical impulses to stimulate nerves and muscles, used for therapeutic purposes in physical medicine applications.
Is the Electrical Neuro-muscular Stimulator single-use or reusable?
The Electrical Neuro-muscular Stimulator is supplied as either a single-use or reusable product, depending on the specific model and configuration selected by the user.
What is the regulatory status of this device?
The Electrical Neuro-muscular Stimulator has FDA 510(k) clearance with product code IPF and model number K840895, authorized on April 24, 1984, and is classified as substantially equivalent.
Who manufactures the Electrical Neuro-muscular Stimulator?
The Electrical Neuro-muscular Stimulator is manufactured by Richards Medical Co., Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.