FDA product code PHL: Powered Exoskeleton
PHL is the FDA product code for powered exoskeleton. It is a Class II device, regulated under 21 CFR 890.3480 and reviewed by the Neurology panel. FDA has cleared 25 510(k) submissions under PHL, 10 in the last five years, from 14 different applicants. The average 510(k) review took 178 days (median 172); 208 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for PHL devices, 1 initiated in the last five years.
Definition
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
| Field | Value |
|---|---|
| Device name | Powered Exoskeleton |
| Device class | Class II |
| Regulation | 21 CFR 890.3480 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for PHL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 148 |
| 2018 | 2 | 144 |
| 2019 | 2 | 132 |
| 2020 | 4 | 113 |
| 2021 | 1 | 408 |
| 2022 | 3 | 143 |
| 2023 | 2 | 209 |
| 2024 | 1 | 172 |
| 2025 | 2 | 236 |
| 2026 | 2 | 216 |
Compare with all 510(k) review times · Search every PHL clearance
Top PHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wandercraft SAS | 4 | 2026-08-03 |
| Ekso Bionics, Inc. | 4 | 2022-06-09 |
| Cyberdyne, Inc. | 3 | 2024-05-07 |
| Re Walk Robotics , Ltd. | 3 | 2023-03-02 |
| Parker Hannifin Corporation | 2 | 2017-09-08 |
9 more applicants have PHL clearances. See the full list in Caduvo.
Most recent PHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254198 | Trexo Robotics, Inc. | Trexo Theo | 2026-09-02 | 253 |
| K260381 | Wandercraft SAS | Eve | 2026-08-03 | 179 |
| K250904 | Wandercraft SAS | Atalante X | 2025-10-24 | 212 |
| K241822 | Rewalk Robotics Ltd. Dba Lifeward | ReWalk® 7 Personal Exoskeleton (50-20-0005) | 2025-03-12 | 261 |
| K233695 | Cyberdyne, Inc. | Medical HAL Lower Limb Type (HAL-ML) | 2024-05-07 | 172 |
Recalls for PHL devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PHL?
PHL is the FDA product code for powered exoskeleton. It is a Class II device, regulated under 21 CFR 890.3480 and reviewed by the Neurology panel.
What device class is PHL?
Class II, regulation 21 CFR 890.3480. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHL?
Across 25 cleared submissions the average was 178 days from receipt to decision (median 172).
Which companies have the most PHL clearances?
Wandercraft SAS (4); Ekso Bionics, Inc. (4); Cyberdyne, Inc. (3); Re Walk Robotics , Ltd. (3); Parker Hannifin Corporation (2).
Have PHL devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PHL
- Run a recall and safety report across every PHL manufacturer
- Watch product code PHL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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