Verimed Myo/Prems
510(k) K874212
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874212 | Date8 Aug 1988 | 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- Withdrawn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, 21 Sep 2026
The Verimed Myo/Prems is a muscle stimulator, a powered medical device. It is classified as a stimulator, muscle, powered, under the product code IPF. The device falls under the medical specialty of Physical Medicine.
The Verimed Myo/Prems is supplied with FDA 510K authorization, with a decision description of Substantially Equivalent. It has a clearance type of Traditional, with the k number K874212. The device is a class 2 medical device, with a decision date of 1988-08-08 and a date received of 1987-10-16.
Other devices from Verimed Holdings, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Verimed Myo/Prems used for?
The Verimed Myo/Prems is used for muscle stimulation in the field of physical medicine.
What type of clearance does the Verimed Myo/Prems have?
The Verimed Myo/Prems has Traditional FDA 510K clearance with a decision description of Substantially Equivalent.
What is the product code for the Verimed Myo/Prems?
The product code for the Verimed Myo/Prems is IPF, classified as a stimulator, muscle, powered.