GWF · Stimulator, Electrical, Evoked Response

Device class

Class II

Regulation 882.1870

Total clearances

2020-10-28 → 2026-06-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.1870

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Alphatec Spine, Inc.	3	1	2026-01-11
Inomed Medizintechnik GmbH	2	0	2023-10-27
Natus Neurology Incorporated	2	0	2025-01-22
Soterix Medical, Inc.	2	0	2024-03-25
Medtronic Xomed, Inc.	1	0	2020-10-28
Time IS Brain, S.L.	1	1	2026-06-27
Neurosoft , Ltd.	1	0	2021-05-22
Cadwell Industries, Inc.	1	0	2023-08-17
Quantalx Neuroscience	1	0	2024-11-05

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.

Code	Type	Description	Confidence	Rationale
92272	CPT	—	Medium	CPT code for evoked response audiometry; electrical stimulation component of evoked response testing
95925	CPT	—	Medium	CPT code for short latency somatosensory evoked potentials with electrical stimulation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-27	K253301	Time IS Brain, S.L.	BraiN20® (BraiN20)
2026-01-11	K252842	Alphatec Spine, Inc.	SafeOp 3: Neural Informatix System
2025-01-22	K243982	Natus Neurology Incorporated	Nicolet EDX
2024-12-12	K243495	Natus Neurology Incorporated	Natus Ultrapro S100 (982A0594)
2024-11-05	K242345	Quantalx Neuroscience	Delphi Stimulator
2024-04-19	K234092	Alphatec Spine, Inc.	SafeOp 3: Neural Informatix Systeem
2024-03-25	K234080	Soterix Medical, Inc.	MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
2023-10-27	K233292	Inomed Medizintechnik GmbH	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
2023-08-17	K230415	Cadwell Industries, Inc.	Cadwell Guardian
2022-03-09	K213849	Alphatec Spine, Inc.	SafeOp 2: Neural Informatix System
2022-01-07	K212166	Inomed Medizintechnik GmbH	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
2021-08-13	K192823	Soterix Medical, Inc.	MEGA-TMS
2021-05-22	K190703	Neurosoft , Ltd.	Neuro-IOM system with Neuro-IOM.NET software
2020-10-28	K200759	Medtronic Xomed, Inc.	NIM Vital, Nerve Integrity Monitor