510(k) · Cleared

Cleared

Recovery+ Model PS 511, Dvtherapy Model PS 511A

K111748510(k) TraditionalCleared Nov 23, 2011154-day reviewClass II21 CFR 870.5800

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

Joy Long · JOW Sleeve, Limb, Compressible

Cleared on Nov 23, 2011 as substantially equivalent to K061125 (Doctors Orders, 2006) and 2 other predicates after a 154-day review. Its family tree reaches back 3 generations to 1992.

Decided: Nov 23, 2011
Review: 154 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K915638 (1992). 23 ancestors in all, the oldest K881632 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
2 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
1 generation backK061125 Dvtcare CA5Doctors Orders · 2006
This deviceK111748 Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K915638	Talley TM200 Intermttent Compression Unit	Progressive Medical Technology, Inc.	1992	—
−2	K022340	Travelair Portable Compression System	Dynamic Air, Inc.	2003	—
−1	K061125	Dvtcare CA5	Doctors Orders	2006	—
0 (this device)	K111748	Recovery+ Model PS 511, Dvtherapy Model PS 511A	Joy Long	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1992	1	0
1993	1	0
1995	3	0
1996	3	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2005	1	0
2006	2	0
2007	1	0

FIG. 1 — Lineage of K111748, 1992–2011Source: 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 JOW? 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 JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 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? (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	Applicant	Decided	Recalls
*	K061125	Dvtcare CA5 Summary page 1 …Model #'s: PS511 and PS511Ia Identification of Predicate Devices [21CFR 807.92 a(3)]: " DVT Therapy 7Doctor's Orders, Inc. DVTcare CA5 K061 125 * DVT Therapy - BioCompression Systems, Bioarterial Plus K072666 " Thermal Therapy - ThermoTek, Inc. NanoTherm/V…	Doctors Orders	2006	—
*	K072666	Bioarterial Plus, Arterial Blood Flow Enhancement System Summary page 1 …ices [21CFR 807.92 a(3)]: " DVT Therapy 7Doctor's Orders, Inc. DVTcare CA5 K061 125 * DVT Therapy - BioCompression Systems, Bioarterial Plus K072666 " Thermal Therapy - ThermoTek, Inc. NanoTherm/VascuTherni K061866 Name Clarification The device as a whole will…	Bio Compression Systems, Inc.	2007	—
*	K061866	Nanotherm, Vascutherm and Prothermo Therapy Wraps Summary page 1 …K061 125 * DVT Therapy - BioCompression Systems, Bioarterial Plus K072666 " Thermal Therapy - ThermoTek, Inc. NanoTherm/VascuTherni K061866 Name Clarification The device as a whole will be marketed as the Recovery+, Model PS5 1. However, the DVT therapy portion of t…	Thermotek, Inc.	2006	—

Also cleared against K061125: 7 other devices →

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?

The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
3 of the 23 ancestors have a recall of any class.
7 other devices also cite its predicate K061125.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

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

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, 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	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

Compression therapy - Including, but not limited to: * Decrease the risk of deep venous thrombosis (DVT); * Aid the blood flow back to the heart; * Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications; * Treatment of pain and swelling of acute periarticular…

Read the full statement (222 words)

Compression therapy - Including, but not limited to:

* Decrease the risk of deep venous thrombosis (DVT);

* Aid the blood flow back to the heart;

* Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications;

* Treatment of pain and swelling of acute periarticular processes, treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia, treatment of pain and swelling postoperatively for bones, joints and soft tissue, treatment of pain and swelling caused by musculoskeletal contusions and athletic injury;

* Treatment of disorders associate with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic edema;

* Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative edema, and bums.

Thermal therapy - Including but not limited to:

* Reduction of general edema (swelling);

* Reduction of edema associated wit soft tissue injuries such as ligament sprains postoperative edema, and bums;

* Treatment of pain and swelling of acute periarticular processes, treatment of pain and swelling following mobilization of shoulder stififness under anesthesia, treatment of pain and swelling postoperatively for bones, joints and soft tissue, treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111748 · printed Nov 5, 2026

Cite this page

510(k) Report. “K111748: Recovery+ Model PS 511, Dvtherapy Model PS 511A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111748

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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