Device class
Class II
Regulation 882.1950
Total clearances
7
2022-03-11 → 2026-08-14
Classification details
Medical specialty
Neurology
Regulation number
882.1950
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Gkc Manufacturing Pty, Ltd. |
1 |
0 |
2022-03-11 |
|
Neuhealth Digital , Ltd. |
1 |
0 |
2025-04-25 |
|
Rune Labs, Inc. |
1 |
0 |
2022-06-10 |
|
Nordic Kinetics AB |
1 |
1 |
2026-06-17 |
|
H2o Bilisim Yazilim |
1 |
0 |
2022-11-17 |
|
New Touch Digital, Inc. |
1 |
0 |
2023-03-17 |
|
Empatica S.r.l.
|
1 |
1 |
2026-08-14 |
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 |
| 95886 |
CPT
|
— |
Medium
|
Quantitative sensorimotor testing; tremor transducers measure movement disorders |
| 95999 |
CPT
|
— |
Low
|
Unlisted neurophysiological monitoring procedure; device may not map to standard CPT codes |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-14 |
K260374 |
Empatica S.r.l.
|
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal |
| 2026-06-17 |
K253055 |
Nordic Kinetics AB
|
Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) |
| 2025-04-25 |
K250153 |
Neuhealth Digital , Ltd.
|
Neu Platform |
| 2023-03-17 |
K221772 |
New Touch Digital, Inc.
|
NeuroRPM |
| 2022-11-17 |
K220820 |
H2o Bilisim Yazilim
|
Parky App |
| 2022-06-10 |
K213519 |
Rune Labs, Inc.
|
Rune Labs Tremor Transducer System |
| 2022-03-11 |
K211887 |
Gkc Manufacturing Pty, Ltd.
|
Personal Kinetigraph (PKG) System Gen 2 Plus |