510(k) Report

510(k) · Cleared

Cleared

RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053

K071113510(k) TraditionalCleared Jul 5, 200776-day reviewClass II21 CFR 882.5810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Restorative Therapies, Inc. · GZI Stimulator, Neuromuscular, External Functional

Cleared on Jul 5, 2007 as substantially equivalent to K060032 (Restorative Therapies, Inc., 2006) after a 76-day review. Its family tree reaches back 2 generations to 1984. 7 later devices descend from it.

Decided
Jul 5, 2007
Review
76 days
Class
Class II
Product code
GZI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K841112 (1984). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2009: 1 descendant cleared2011: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant clearedK841112 · Tti Rehabilatation Gym Sys · Therapeutic Technologies, Inc. · 1984K060032 · RT300-S, Model FA100052; RT300-SP, Model FA100053 · Restorative Therapies, Inc. · 200619801990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 4 descendants K060032 · RT300-S, Model FA100052; RT300-SP, Model FA100053 · Restorative Therapies, Inc. · 2006K841112 · Tti Rehabilatation Gym Sys · Therapeutic Technologies, Inc. · 19840
  1. Root · 2 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
  2. 1 generation backK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
  3. This deviceK071113 RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc. · 2007
  4. Descendant · cites it directly · 6 of its ownK071486 RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007
  5. Descendant · 2 generations on · 5 of its ownK072398 RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007
  6. Descendant · 3 generations on · 4 of its ownK090750 RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009
  7. Descendant · 4 generations on · 1 of its ownK160614 Xcite Clinical StationRestorative Therapies, Inc. · 2016
  8. Descendant · 4 generations on · 0 of its ownK162470 RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 22009: 12011: 22016: 12017: 1
2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K071486RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007 · cites it directly6descendants
  • K072398RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007 · 2 generations on5descendants
  • K090750RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009 · 3 generations on4descendants
  • K160614Xcite Clinical StationRestorative Therapies, Inc. · 2016 · 4 generations on1descendant
  • K162470RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K841112Tti Rehabilatation Gym SysTherapeutic Technologies, Inc.1984—
−1K060032RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc.2006—
0 (this device)K071113RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc.2007—
+1K071486RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc.2007—
+2K072398RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc.2007—
+3K090750RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc.2009—
+4K160614Xcite Clinical StationRestorative Therapies, Inc.2016—
+4K162470RT300 FES cycle ergometerRestorative Therapies, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200910
201120
201610
201710
FIG. 1 — Lineage of K071113, 1984–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243828 Cionic Neural Sleeve (NS-200)score 12.9 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K060032RT300-S, Model FA100052; RT300-SP, Model FA100053
Summary page 1
…:Powered Muscle Stimulator (3) Identification of the legally marketed device to which the submitter claims equivalence: RESTORATIVE THERAPIES, INC. product: "RT300-S", K060032, a class 2 device (4) A description of the device that is the subject of the premarket notification submission. The RT300-S is…
Restorative Therapies, Inc.2006—

Also cleared against K060032: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071486RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc.20076

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 23 years and passes through 2 companies; a new generation was cleared every 21.9 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K071486 (Restorative Therapies, Inc., 2007) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K060032.

How does its category compare?

All GZI devices

GZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GZI

2in 2025

2007: 42008: 12009: 12011: 62012: 22013: 22014: 32015: 12016: 12017: 62018: 22019: 22020: 22021: 12022: 42023: 12024: 22025: 2
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZI

110in 2022

2007: 81 days median2011: 139 days median2014: 299 days median2017: 168 days median2022: 110 days median
2007high 299 (2014) · low 81 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZI

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZI

3in 2025

2007: 12008: 22009: 82010: 12011: 32012: 22014: 22015: 32017: 22018: 12019: 42021: 12022: 32023: 12024: 12025: 3
2007high 8 (2009) · low 0 (2013)2025

MAUDE reports naming product code GZI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200748101
20081—12
20091—08
20100—01
2011613903
20122—02
20132—00
2014329902
20151—03
20161—00
2017616802
20182—01
20192—04
20202—00
20211—01
2022411003
20231—01
20242—01
20252—03
20260—0—

What is it indicated for?

The RT300-S (adult version) and RT300-SP (pediatric version) are intended for

general rehabilitation for:

1. Relaxation of muscle spasms

2. Prevention or retardation of disuse atrophy

3. Increasing local blood circulation

4. Maintaining or increasing range of motion

The RT300-SP (pediatric version), is intended for population ages 4 to 12 years.

Indications for use as stated in the FDA summary.

Also cleared against K060032

1 other device cites the same predicate.

  • K073237Rehastim & RehamoveHasomed GmbH · 2007

More from Restorative Therapies, Inc.

10 FDA decisions under this applicant name. See the company

  • K162470RT300 FES cycle ergometerRestorative Therapies, Inc. · 2017
  • K160614Xcite Clinical StationRestorative Therapies, Inc. · 2016
  • K103370RT200Restorative Therapies, Inc. · 2011
  • K103366RT600Restorative Therapies, Inc. · 2011
  • K090750RT300-SL, Model FA100052; RT300-Slsa, Model FA104581Restorative Therapies, Inc. · 2009

Recent decisions in GZI

The GZI category page

  • K242704Synchrony (20-3000)Synapse Biomedical, Inc. · 2025
  • K243828Cionic Neural Sleeve (NS-200)Cionic, Inc. · 2025
  • K240632Neuvotion NeuStim NN-01Neuvotion, Inc. · 2024
  • K233006MyndMove, MyndMove 2.0Myndtec, Inc. · 2024
  • K230997EvoWalk 1.0 SystemEvolution Devices, Inc. · 2023

https://510kreport.com/device/K071113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071113: RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071113

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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