Device class
Class II
Regulation 890.3480
Total clearances
15
2020-05-26 → 2026-09-02
Definition
What is Powered Exoskeleton
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.
Classification details
Medical specialty
Physical Medicine
Regulation number
890.3480
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Wandercraft SAS
|
4 |
2 |
2026-08-03 |
|
Re Walk Robotics , Ltd. |
2 |
0 |
2023-03-02 |
|
Cyberdyne, Inc. |
2 |
0 |
2024-05-07 |
|
Ekso Bionics, Inc. |
2 |
0 |
2022-06-09 |
|
Exoatlet Asia Co. , Ltd. |
1 |
0 |
2021-07-16 |
|
B-Temia, Inc. |
1 |
0 |
2020-09-09 |
|
Samsung Electronics Co., Ltd.
|
1 |
0 |
2022-04-21 |
|
Rewalk Robotics Ltd. Dba Lifeward |
1 |
0 |
2025-03-12 |
|
Trexo Robotics, Inc.
|
1 |
1 |
2026-09-02 |
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 |
| L3932 |
HCPCS
|
— |
High
|
Powered exoskeleton, lower limbs; standard HCPCS orthotics code for powered exoskeletons |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-02 |
K254198 |
Trexo Robotics, Inc.
|
Trexo Theo |
| 2026-08-03 |
K260381 |
Wandercraft SAS
|
Eve |
| 2025-10-24 |
K250904 |
Wandercraft SAS
|
Atalante X |
| 2025-03-12 |
K241822 |
Rewalk Robotics Ltd. Dba Lifeward
|
ReWalk® 7 Personal Exoskeleton (50-20-0005) |
| 2024-05-07 |
K233695 |
Cyberdyne, Inc.
|
Medical HAL Lower Limb Type (HAL-ML) |
| 2023-12-13 |
K232077 |
Wandercraft SAS
|
Atalante X |
| 2023-03-02 |
K221696 |
Re Walk Robotics , Ltd.
|
ReWalk P6.0 |
| 2022-12-29 |
K221859 |
Wandercraft SAS
|
Atalante |
| 2022-06-09 |
K220988 |
Ekso Bionics, Inc.
|
EksoNR |
| 2022-04-21 |
K213452 |
Samsung Electronics Co., Ltd.
|
GEMS-H |
| 2021-07-16 |
K201473 |
Exoatlet Asia Co. , Ltd.
|
ExoAtlet-II |
| 2020-10-02 |
K201559 |
Cyberdyne, Inc.
|
HAL for Medical Use(Lower Limb type) |
| 2020-09-09 |
K201539 |
B-Temia, Inc.
|
Keeogo Dermoskeleton System |
| 2020-06-19 |
K200574 |
Ekso Bionics, Inc.
|
EksoNR |
| 2020-05-26 |
K200032 |
Re Walk Robotics , Ltd.
|
ReWalk P6.0 |