Chrysalis Intelligence · Product Codes · GYB

GYB · Unclassified

10 clearances · 9 unique sponsors

Device class
Regulation —
Total clearances
10
2020-01-17 → 2025-04-08
Last 12 months
0
Unique sponsors
9
Medical specialty
Review panel
Regulation number
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
Spes Medica Srl 2 0 2021-12-01
Top-Rank Health Care Co., Ltd. 1 0 2022-12-13
Tone-A-Matic International, Inc. 1 0 2022-09-23
Wuhan Greentek Pty , Ltd. 1 0 2021-11-08
Premier North America, Inc. 1 0 2023-09-15
Shenzhen Ulike Smart Electronics Co., Ltd. 1 0 2025-04-08
Somnomedics GmbH 1 0 2022-06-15
Nihon Kohden Corporation 1 0 2020-02-07
Guangzhou Xinbo Electronic Co., Ltd. 1 0 2020-11-25
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
A4556 HCPCS Electrodes, (e.g., apnea monitor), per pair ✓ CMS-verified description High Electrode/transducer for use with EEG; electroconductive media is a supply component for electrode application
A4649 HCPCS Surgical supply; miscellaneous ✓ CMS-verified description Medium Surgical supplies; electroconductive gel/media as consumable supply
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-04-08 K243749 Shenzhen Ulike Smart Electronics Co., Ltd. Jmoon Conductive Gel
2023-09-15 K220735 Premier North America, Inc. Avologi Gel Primer (Model: Av25)
2022-12-13 K222770 Top-Rank Health Care Co., Ltd. Conductive Gel
2022-09-23 K221724 Tone-A-Matic International, Inc. Conductive Gel
2022-06-15 K212325 Somnomedics GmbH EEG-acp
2021-12-01 K212326 Spes Medica Srl AC Cream - Conductive paste
2021-11-08 K212787 Wuhan Greentek Pty , Ltd. GT5 conductive & abrasive gel
2020-11-25 K200402 Guangzhou Xinbo Electronic Co., Ltd. DR-HO'S Electro Therapy Conductive Gel
2020-02-07 K191975 Nihon Kohden Corporation Elefix V Paste for EEG & EMG
2020-01-17 K192606 Spes Medica Srl SAC2 - Electrode Cream