Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3480](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3480) → PHL — Powered Exoskeleton # PHL · Powered Exoskeleton _Physical Medicine · 21 CFR 890.3480 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL ## Overview - **Product Code:** PHL - **Device Name:** Powered Exoskeleton - **Regulation:** [21 CFR 890.3480](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3480) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes. ## Classification Rationale Class II (special controls). The special controls for this device are: ## Special Controls In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls: *Classification.* Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) Design characteristics must ensure geometry and materials composition are consistent with intended use. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use; (ii) Simulated use testing ( *i.e.,* cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present; (iv) The accuracy of device features and safeguards; and (v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance. (6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: (i) Level of supervision necessary, and (ii) Environment of use ( *e.g.,* indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use. (8) Labeling for the Physician and User must include the following: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk. (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations; (B) Instructions on fitting the patient; (C) Instructions and explanations of all available programs and how to program the device; (D) Instructions and explanation of all controls, input, and outputs; (E) Instructions on all available modes or states of the device; (F) Instructions on all safety features of the device; and (G) Instructions for properly maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness. (iv) Pertinent non-clinical testing information ( *e.g.,* EMC, battery longevity).(v) A detailed summary of the clinical testing including: (A) Adverse events encountered under use conditions, (B) Summary of study outcomes and endpoints, and (C) Information pertinent to use of the device including the conditions under which the device was studied ( *e.g.,* level of supervision or assistance, and environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain). ## Recent Cleared Devices (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250904](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K250904.md) | Atalante X | Wandercraft SAS | Oct 24, 2025 | SESE | | [K241822](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K241822.md) | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | Mar 12, 2025 | SESE | | [K233695](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K233695.md) | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | May 7, 2024 | SESE | | [K232077](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K232077.md) | Atalante X | Wandercraft SAS | Dec 13, 2023 | SESE | | [K221696](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K221696.md) | ReWalk P6.0 | Re Walk Robotics , Ltd. | Mar 2, 2023 | SESE | | [K221859](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K221859.md) | Atalante | Wandercraft SAS | Dec 29, 2022 | SESE | | [K220988](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K220988.md) | EksoNR | Ekso Bionics, Inc. | Jun 9, 2022 | SESE | | [K213452](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K213452.md) | GEMS-H | Samsung Electronics Co., Ltd. | Apr 21, 2022 | SESE | | [K201473](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K201473.md) | ExoAtlet-II | Exoatlet Asia Co. , Ltd. | Jul 16, 2021 | SESE | | [K201559](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K201559.md) | HAL for Medical Use(Lower Limb type) | Cyberdyne, Inc. | Oct 2, 2020 | SESE | | [K201539](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K201539.md) | Keeogo Dermoskeleton System | B-Temia, Inc. | Sep 9, 2020 | SESE | | [K200574](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K200574.md) | EksoNR | Ekso Bionics, Inc. | Jun 19, 2020 | SESE | | [K200032](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K200032.md) | ReWalk P6.0 | Re Walk Robotics , Ltd. | May 26, 2020 | SESE | | [K190337](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K190337.md) | ReWalk Restore | Re Walk Robotics , Ltd. | Jun 3, 2019 | SESE | | [K183152](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K183152.md) | Phoenix | Us Bionics, Inc. (Dba Suitx) | Apr 17, 2019 | SESE | | [K181294](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K181294.md) | Honda Walking Assist Device | Honda Motor Company, Ltd. | Dec 14, 2018 | SESE | | [K173530](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K173530.md) | Indego(R) | Parker-Hannifin Corporation | Jan 31, 2018 | SESE | | [K171909](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K171909.md) | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | Dec 17, 2017 | SESE | | [K171334](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K171334.md) | Indego | Parker Hannifin Corporation | Sep 8, 2017 | SESE | | [K160987](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL/K160987.md) | ReWalk(TM) | Rewalk Robotics, Inc. | Jul 22, 2016 | SESE | ## Top Applicants - Ekso Bionics, Inc. — 4 clearances - Cyberdyne, Inc. — 3 clearances - Re Walk Robotics , Ltd. — 3 clearances - Wandercraft SAS — 3 clearances - Parker Hannifin Corporation — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/PHL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com