# Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center (specification developer, Tokorozawa Saitama, JP): 5 new FDA device listings, incl. standard polysomnograph with electroencephalograph

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center |
| Owner / operator | Nihon Kohden Corp. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Tokorozawa Saitama, JP |
| New listings | 5 |
| Devices | Standard Polysomnograph With Electroencephalograph; Stimulator, Photic, Evoked Response; Full-Montage Standard Electroencephalograph; Non-Normalizing Quantitative Electroencephalograph Software; Tape And Bandage, Adhesive |
| Product codes | OLV, GWE, GWQ, OLT, KGX |
| Device classes | Class I, Class II |
| Medical specialties | Neurology, General Hospital |
| Brand names | LS-940A-ARM; LS-940A; JE-940A, EEG Amplifier Unit; EEG-1260A Neurofax System; LS-940A-OLY; JE-944A, Mini Electrode Junction Box; LS-940A, Photic Stimulator; JE-940A |
| First new listing | 2026-06-05 |
| Latest new listing | 2026-08-06 |
| FDA registration number | 3013501110 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.