510(k) · Cleared

Cleared

Thermo-Therapy, Models TT-101, TT-201, and TT-202

K011768510(k) TraditionalCleared Aug 3, 200157-day reviewClass II21 CFR 890.5100

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

Thermo-Electric Co. · LSB Unit, Fluidotherapy

Cleared on Aug 3, 2001 as substantially equivalent to K871802 (Henley Intl., 1987) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1987.

Decided: Aug 3, 2001
Review: 57 days
Class: Class II
Product code: LSB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K871802 (1987). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK871802 Model K210 and K211 Fluidotherapy UnitsHenley Intl. · 1987
This deviceK011768 Thermo-Therapy, Models TT-101, TT-201, and TT-202Thermo-Electric Co. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871802	Model K210 and K211 Fluidotherapy Units	Henley Intl.	1987	—
0 (this device)	K011768	Thermo-Therapy, Models TT-101, TT-201, and TT-202	Thermo-Electric Co.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K011768, 1987–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K871802	Model K210 and K211 Fluidotherapy Units Summary page 1 …ny other products for the use in the professional physical and occupational therapy market. - The substantially equivalent (SE) product to our Thermo-Therapy is 510 (K) K871802 and 510 (K) K896817 both product code L.SB and commonly known as IFluidotherapy. The Fluidotherapy type devices describe a proce…	Henley Intl.	1987	—
*	K896817	Model T11 Fluidotherapy Unit Summary page 1 …r the use in the professional physical and occupational therapy market. - The substantially equivalent (SE) product to our Thermo-Therapy is 510 (K) K871802 and 510 (K) K896817 both product code L.SB and commonly known as IFluidotherapy. The Fluidotherapy type devices describe a process where ground cell…	Henley Intl.	1991	—

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.

How does its category compare?

All LSB devices

LSB Unit, Fluidotherapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LSB

FDA has decided no LSB device since 2007.

Median 510(k) review, days · LSB

Too few LSB 510(k)s in any year since 2007 to give a median.

Recalls per year · LSB

No recall names LSB since 2007.

Adverse event reports per year · LSB

2in 2025

2007high 3 (2015) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	1
2012	—	0
2013	—	0
2014	—	0
2015	—	3
2016	—	0
2017	—	0
2018	—	1
2019	—	2
2020	—	0
2021	—	1
2022	—	0
2023	—	0
2024	—	0
2025	—	2
2026	—	—

What is it indicated for?

Increase of Local Blood Circulation.

Treatment of Range of Motion when combined with exercise.

Treatment for minor pain and stiffness of non—rheumatoid arthritis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011768 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011768: Thermo-Therapy, Models TT-101, TT-201, and TT-202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011768

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026