# K111748: Recovery+ Model PS 511, Dvtherapy Model PS 511A

- Pathway: 510(k) (Traditional)
- Applicant: Joy Long
- Decided: Nov 23, 2011 after 154 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915638 (1992). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061125: Dvtcare CA5, Doctors Orders (2006) Summary page 1.
- K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System, Bio Compression Systems, Inc. (2007) Summary page 1.
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps, Thermotek, Inc. (2006) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K111748
Methodology: https://510kreport.com/methodology