Rt300-S, Rt300-Sp (pediatric Version), Model Fa100052, Fa100053
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071486 FDA 510(k)
- FDA Product Code
- GZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5810 FDA 510(k)
- Regulation Number
- 882.5810 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RT300-S and RT300-SP (Pediatric Version) are External Functional Neuromuscular Stimulators, classified under FDA product code GZI. These devices deliver functional electrical stimulation to relax muscle spasms, prevent or retard disuse atrophy, and improve local blood circulation and range of motion. The pediatric version is specifically designed for use in patients aged 4 to 12 years.
These devices are intended for clinical and home-based rehabilitation settings and are supplied as reusable medical equipment. They are not sterile and must be cleaned and maintained according to manufacturer guidelines. The RT300-S and RT300-SP have received FDA 510(k) clearance under Special Review and comply with the Medical Device Directive (MDD). No MRI safety information is specified in the available data.
Frequently asked questions
What clinical conditions is the RT300-S neuromuscular stimulator designed to address in pediatric patients?
The RT300-SP (pediatric version) is specifically designed for patients aged 4 to 12 years to deliver functional electrical stimulation for relaxing muscle spasms, preventing or slowing muscle wasting (disuse atrophy), and improving local blood circulation and range of motion. It is intended for use in clinical and home-based rehabilitation settings.
Are the RT300-S and RT300-SP devices single-use or reusable, and what cleaning requirements apply?
The RT300-S and RT300-SP are reusable medical devices and are not sterile. They must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper function and hygiene.
How do I determine if this device is appropriate for my facility’s needs, given its regulatory history?
The RT300-S and RT300-SP have received FDA 510(k) clearance under Special Review, meaning they were deemed substantially equivalent to a legally marketed predicate device. They also comply with the Medical Device Directive (MDD). The device is classified under FDA product code GZI and is intended for use in neurology-related applications, as reflected in the advisory committee review.
What size or model variations are available for pediatric patients, and how do they differ from the standard RT300-S?
The RT300-SP is the pediatric-specific version of the RT300-S, designed specifically for patients aged 4 to 12 years. While the exact technical differences between the RT300-S and RT300-SP are not detailed in the provided data, the pediatric version is tailored to accommodate smaller patient sizes and age ranges.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Rt300-s, Model Fa100052, Rt300-sp (Pediatric Version), Model Fa100053 ..., Rt300-s, Model Fa100052; Rt300-sp, Model Fa100053, Rt300-s, Model Fa100052, Rt300-sp (Pediatric Version), Model Fa100053, Rt300-s, Model Fa100052, Rt300-sp (Pediatric Version), Model Fa100053
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K071486 | Class II | Active |
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Manufacturer
- Manufacturer
- Restorative Therapies, Inc.
Sources (2)
- FDA 510(k) K071486 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026