Two Cyberdyne exoskeletons, two very different meanings of "FDA"

Cyberdyne sells two medical exoskeletons in the United States, both branded Medical HAL, both controlled the same way — and each stands on a different regulatory footing. One went through the FDA's 510(k) review three times. The other is merely registered as a Class I device. On a marketing page both can be described as being with the FDA. The leg device, Medical HAL Lower Limb Type, holds three 510(k) clearances in the agency's own database: K171909 on 17 December 2017, K201559 on 2 October 2020 and K233695 on 7 May 2024. That route requires the manufacturer to show the agency that the device is substantially equivalent to one already on the market, and it is repeated whenever the product changes materially — which is why there are three entries rather than one. The single-joint device, HAL-SJ, takes the other path. Cyberdyne states on its own product page that the unit is CE marked under the older European Medical Device Directive and registered with the FDA as a Class I device. Class I registration is a listing obligation, not a review of the device; for most Class I products no clearance decision is made at all, and none appears in the 510(k) database. Neither position is irregular — Class I is the correct category for a large family of low-risk devices, and the two HAL products are not equivalent machines. The 1.5 kg single-joint brace drives one elbow, knee, ankle or shoulder at a patient's bedside; the leg exoskeleton weighs up to 14 kg and is used for gait training in spinal cord injury, stroke and cerebral palsy. What the pairing shows is how little the phrase "FDA" carries on its own when it appears in a robotics spec sheet. Two devices from one manufacturer, sharing a control principle and a product name, sit on opposite sides of a line the buyer cannot see from the brochure. The catalogue records the specific basis for each: three clearance numbers with dates for the leg device, Class I registration for the single-joint one.