Device class
Class II
Regulation 882.5810
Total clearances
12
2020-03-04 → 2025-06-05
Classification details
Medical specialty
Neurology
Regulation number
882.5810
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 97032 |
CPT
|
— |
High
|
Application of neuromuscular electrical stimulation; external functional neuromuscular stimulation for therapeutic use |
| E0745 |
HCPCS
|
Neuromuscular stimulator, electronic shock unit ✓ CMS-verified description |
High
|
Neuromuscular stimulator for external application; standard HCPCS for external functional stimulation device |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-06-05 |
K242704 |
Synapse Biomedical, Inc.
|
Synchrony (20-3000) |
| 2025-05-02 |
K243828 |
Cionic, Inc.
|
CIONIC NEURAL SLEEVE (NS-200) |
| 2024-11-22 |
K240632 |
Neuvotion, Inc.
|
Neuvotion NeuStim NN-01 |
| 2024-06-25 |
K233006 |
Myndtec, Inc.
|
MyndMove, MyndMove 2.0 |
| 2023-12-28 |
K230997 |
Evolution Devices, Inc.
|
EvoWalk 1.0 System |
| 2022-07-21 |
K221823 |
Cionic
|
Cionic Neural Sleeve NS-100 |
| 2022-04-25 |
K213925 |
Myolyn, LLC
|
MyoCycle MC-2 (Home / Home + / Pro / Pro +) |
| 2022-03-03 |
K212149 |
Myndtec, Inc.
|
MyndMove 2.0 |
| 2022-02-14 |
K213622 |
Cionic
|
Cionic Neural Sleeve NS-100 |
| 2021-11-05 |
K202110 |
Guangzhou Longest Science & Technology Co., Ltd.
|
MStim Drop Model: LGT-233 |
| 2020-09-23 |
K193276 |
Shenzhen Xft Medical Limited
|
Nerve and Muscle Stimulator |
| 2020-03-04 |
K200262 |
Bioness, Inc.
|
L100 Go System |