510(k) · Cleared

Cleared

Tti Rehabilatation Gym Sys

K841112510(k) TraditionalCleared Apr 4, 198420-day reviewClass II21 CFR 890.5850

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

Therapeutic Technologies, Inc. · IPF Stimulator, Muscle, Powered

Cleared on Apr 4, 1984 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided: Apr 4, 1984
Review: 20 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 0

16 later devices descend from it, 4 citing it directly.

This deviceK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
Descendant · cites it directly · 12 of its ownK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
Descendant · 2 generations on · 8 of its ownK073237 Rehastim & RehamoveHasomed GmbH · 2007
Descendant · 2 generations on · 7 of its ownK071113 RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc. · 2007
Descendant · 3 generations on · 6 of its ownK071486 RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007
Descendant · 4 generations on · 5 of its ownK072398 RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 4 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 16 · See all

K060032RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006 · cites it directly12descendants
K073237Rehastim & RehamoveHasomed GmbH · 2007 · 2 generations on8descendants
K071113RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053Restorative Therapies, Inc. · 2007 · 2 generations on7descendants
K071486RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053Restorative Therapies, Inc. · 2007 · 3 generations on6descendants
K072398RT300-S and RT300-SP Fes Cycle ErgometerRestorative Therapies, Inc. · 2007 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K841112	Tti Rehabilatation Gym Sys	Therapeutic Technologies, Inc.	1984	—
+1	K060032	RT300-S, Model FA100052; RT300-SP, Model FA100053	Restorative Therapies, Inc.	2006	—
+2	K073237	Rehastim & Rehamove	Hasomed GmbH	2007	—
+2	K071113	RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053	Restorative Therapies, Inc.	2007	—
+3	K071486	RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053	Restorative Therapies, Inc.	2007	—
+4	K072398	RT300-S and RT300-SP Fes Cycle Ergometer	Restorative Therapies, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	4	0
2009	1	0
2011	3	0
2014	1	0
2016	1	0
2017	3	0
2022	1	0

FIG. 1 — Lineage of K841112, 1984–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IPF? 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 IPF device

#1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060032	RT300-S, Model FA100052; RT300-SP, Model FA100053	Restorative Therapies, Inc.	2006	12
K090750	RT300-SL, Model FA100052; RT300-Slsa, Model FA104581	Restorative Therapies, Inc.	2009	4
K050036	Fes Cycle Ergometer, Model RT300-S	Restorative Therapies, Inc.	2005	2
K103370	RT200	Restorative Therapies, Inc.	2011	0

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?

Of its descendants, K060032 (Restorative Therapies, Inc., 2006) has gone furthest, with 12 descendants of its own.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPF

3in 2025

2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IPF

8in 2025

2007high 213 (2008) · low 2 (2017)2025

MAUDE reports naming product code IPF, 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	8	143	0	11
2008	6	140	1	213
2009	7	216	0	150
2010	4	121	0	14
2011	4	275	1	25
2012	4	269	3	16
2013	10	180	0	6
2014	4	264	0	19
2015	3	43	0	11
2016	7	113	0	8
2017	5	110	0	2
2018	5	73	0	3
2019	4	133	0	10
2020	9	121	0	13
2021	15	98	0	3
2022	7	108	0	4
2023	9	255	1	8
2024	7	201	0	5
2025	3	257	0	8
2026	3	206	0	—

https://510kreport.com/device/K841112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K841112: Tti Rehabilatation Gym Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841112

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026