Chrysalis Intelligence · Product Codes · KOI

KOI · Stimulator, Nerve, Peripheral, Electric

Anesthesiology · 10 clearances · 6 unique sponsors

Device class
Class II
Regulation 868.2775
Total clearances
10
2020-04-02 → 2026-05-22
Last 12 months
2
Unique sponsors
6
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.2775
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Nihon Kohden Corporation 3 0 2022-07-21
MIPM Mammendorfer Institut für Physik und Medizin GmbH 2 1 2025-10-21
Senzime AB 2 1 2026-05-22
Blink Device Company 1 0 2020-04-02
Idmed 1 0 2025-06-23
Nerbio Medical Software Platforms, Inc. 1 0 2024-12-05
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E0730 HCPCS Transcutaneous electrical nerve stimulation (tens) device, four or more leads, for multiple nerve stimulation ✓ CMS-verified description High Transcutaneous electrical nerve stimulation (TENS) unit, two lead
64550 CPT Medium Application of surface (transcutaneous) neurostimulator
64575 CPT Medium Neurostimulator; implantable pulse generator programming
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-22 K261098 Senzime AB TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
2025-10-21 K250887 MIPM Mammendorfer Institut für Physik und Medizin GmbH Neuromuscular Transmission Monitor TOF3D (2510091)
2025-06-23 K243339 Idmed WiTOF
2024-12-05 K242525 Nerbio Medical Software Platforms, Inc. iTOF®
2022-08-17 K220530 Senzime AB Tetragraph Neuromuscular Transmission Monitor
2022-07-21 K220976 Nihon Kohden Corporation Life Scope PT BSM-1700 Series Bedside Monitor
2022-05-05 K212434 MIPM Mammendorfer Institut für Physik und Medizin GmbH Neuromuscular Transmission Monitor TOF3D
2021-12-29 K213316 Nihon Kohden Corporation Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
2021-05-02 K201949 Nihon Kohden Corporation Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
2020-04-02 K192958 Blink Device Company TwitchView System