510(k) · Cleared
ClearedRT300-SL, Model FA100052; RT300-Slsa, Model FA104581
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restorative Therapies, Inc. · GZI Stimulator, Neuromuscular, External Functional
Cleared on Aug 5, 2009 as substantially equivalent to K072398 (Restorative Therapies, Inc., 2007) and 2 other predicates after a 138-day review. Its family tree reaches back 5 generations to 1984. 4 later devices descend from it.
- Decided
- Aug 5, 2009
- Review
- 138 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K841112 (1984). 6 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 4 generations backK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
- 3 generations backK071113 RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc. · 2007
- 2 generations backK071486 RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007
- 1 generation backK072398 RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007
- This deviceK090750 RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK160614 Xcite Clinical StationRestorative Therapies, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK162470 RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK103370 RT200Restorative Therapies, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK103366 RT600Restorative Therapies, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K160614Xcite Clinical StationRestorative Therapies, Inc. · 2016 · cites it directly1descendant
- K162470RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017 · cites it directly0descendants
- K103370RT200Restorative Therapies, Inc. · 2011 · cites it directly0descendants
- K103366RT600Restorative Therapies, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −4 | K060032 | RT300-S, Model FA100052; RT300-SP, Model FA100053 | Restorative Therapies, Inc. | 2006 | — |
| −3 | K071113 | RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053 | Restorative Therapies, Inc. | 2007 | — |
| −2 | K071486 | RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053 | Restorative Therapies, Inc. | 2007 | — |
| −1 | K072398 | RT300-S and RT300-SP Fes Cycle Ergometer | Restorative Therapies, Inc. | 2007 | — |
| 0 (this device) | K090750 | RT300-SL, Model FA100052; RT300-Slsa, Model FA104581 | Restorative Therapies, Inc. | 2009 | — |
| +1 | K160614 | Xcite Clinical Station | Restorative Therapies, Inc. | 2016 | — |
| +1 | K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | 2017 | — |
| +1 | K103370 | RT200 | Restorative Therapies, Inc. | 2011 | — |
| +1 | K103366 | RT600 | Restorative Therapies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZI device
- #1 K243828 Cionic Neural Sleeve (NS-200)score 12.9 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072398 | RT300-S and RT300-SP Fes Cycle ErgometerSummary page 1AUG 0 62009 510(k) Summary Note: Changes from K072398 RT300 Summary of Safety and Effectiveness are shown in italics. RT300 Summary of Safety and Effectivenes… | 2007 |
| * | K841112 | Tti Rehabilatation Gym SysSummary page 1…device to which the submitter claims equivalence: RESTORATIVE THERAPIES, INC. product: "RT300", K072398, a class 2 device THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device. Relates to Stimwear only. HASOMED GMBH product: "REHASTIM & REHAMOVE", K073237, a class 2 device. Relates to… | 1984 |
| * | K073237 | Rehastim & RehamoveSummary page 1…72398, a class 2 device THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112, a class 2 device. Relates to Stimwear only. HASOMED GMBH product: "REHASTIM & REHAMOVE", K073237, a class 2 device. Relates to stand alone stimulator use only. (4) A description of the device that is the subject of the premar… | 2007 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K160614 (Restorative Therapies, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZI
110in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZI
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZI
3in 2025
MAUDE reports naming product code GZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 81 | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 6 | 139 | 0 | 3 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 299 | 0 | 2 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | 168 | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | 110 | 0 | 3 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RT300 (adult and pediatric version) are intended for general rehabilitation for:
a. Relaxation of muscle spasms
b. Prevention or retardation of disuse atrophy
c. Increasing local blood circulation
d. Maintaining or increasing range of motion
The RT300 is for prescription use only.
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090750: RT300-SL, Model FA100052; RT300-Slsa, Model FA104581.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090750
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026