EASISTIM
by Promed Corp.
510(k) K861091
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861091 | Date2 Jun 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOI
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2775
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The EASISTIM is a peripheral nerve electric stimulator device used in anesthesiology applications. It is designed to stimulate peripheral nerves for medical purposes.
The EASISTIM is supplied by Promed Corp. and has FDA 510(k) clearance with the product code KOI. The device is classified as Class II and is intended for use in clinical settings. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.
Other devices from Promed Corp.
Questions
AI-generated answers, 6 Oct 2026
What clinical purpose does the EASISTIM serve?
The EASISTIM is intended to deliver electrical stimulation to peripheral nerves during anesthesiology procedures, helping clinicians achieve desired nerve activation for diagnostic or therapeutic purposes.
How is the EASISTIM supplied and what regulatory clearance does it have?
Promed Corp. supplies the device, and it has received FDA 510(k) clearance with product code KOI, indicating it is substantially equivalent to a legally marketed predicate and classified as a Class II device.
Is there information on whether the EASISTIM is sterile or single‑use?
The provided data do not specify sterility, single‑use, or reusable status, so users must refer to the manufacturer’s labeling or instructions for those details.
What storage or handling requirements apply to the EASISTIM?
No storage conditions are listed in the device data; therefore, standard clinical device handling practices should be followed until the manufacturer provides specific guidance.