FDA product code · Neurology · Class 2
PHL: Powered Exoskeleton
PHL is FDA's product code for "Powered Exoskeleton": a Class 2 device classified under 21 CFR 890.3480, reviewed by the Neurology panel.
510(k) review time for PHL
Across 19 510(k) clearances under PHL decided from 2018-01-01 to 2026-10-06, the median was 172 days from FDA receipt to decision. Half took between 112 and 212 days, and 80% were decided within 228 days. These are past clearances, not a forecast for a new submission.
| Fastest | 66 |
|---|---|
| 25th percentile | 112 |
| Median | 172 |
| 75th percentile | 212 |
| 80th percentile | 228 |
| 90th percentile | 262 |
| Slowest | 408 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite PHL
2 FDA recognized consensus standards cite PHL, among them ISO 10328 Second edition 2016-06-01; IEC 80601-2-78 Edition 1.0 2019-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 16-231 ISO 10328 Second edition 2016-06-01 — Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods
- 16-232 IEC 80601-2-78 Edition 1.0 2019-07 — Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation assessment compensation or alleviation
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.