(216 days)
Not Found
No
The device description focuses on electromechanical components and a fixed inflation sequence, with no mention of AI/ML terms or adaptive behavior based on data.
Yes.
The device's intended use is to treat existing medical conditions (pain, swelling, ulceration, risk of dermatological impact, infection, and amputation) by improving circulation, which makes it a therapeutic device.
No
The device's intended use is to improve circulation and treat associated symptoms like pain and swelling, which is a therapeutic function. It does not mention diagnosing any condition.
No
The device description explicitly states it is an "electromechanical pneumatic device" that includes a compressor, timer, regulator, and gage, and has physical dimensions and weight. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to improve the return circulation of body fluid in a patient's extremities. This is a therapeutic treatment applied directly to the patient's body.
- Device Description: The device is an electromechanical pneumatic device that inflates a sleeve on the patient's extremity. This is a physical therapy or medical device used externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any such specimens.
The device described is a therapeutic medical device used for external compression therapy.
N/A
Intended Use / Indications for Use
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders. Complies with physician-prescribed treatment pressures.
Product codes
74JQW
Device Description
This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs. This device is a new state-of-the-art sequential compression pump/ and appliance system which produces better results than single-4 pressure systems currently in use. At end of the pressure phase of the treatment cycle, this device disengages cells in quick succession, from proximal to distal, to ensure a reverse gradient is never applied despite any slight irregularities inherent in mechanical pneumatic systems. Cell C is disengaged just before cell B and, in turn. B iust before A. The proposed device is factory-preset for a maximum pressure less than 101 mm Hg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, clinics, patient homes, and elsewhere
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical test data:
- Cell pressures of prototype device were measured using separate precision regulators for each appliance cell.
- Pressures in each cell reach the prescribed setting 10 or more seconds before the next cell is activated.
- Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.
Clinical test data: Not applicable
Key Metrics
Not Found
Predicate Device(s)
K830577B, K871271, K874688, K921608
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
NOV - 6 1996
510(k) Summary 4.
4.1. submitter
-
4.1.1. Wright Linear Pump, Inc. 303 Robinson Road Imperial, PA 15126
412 695-0800 FAX 412 695-0406 -
4.1.2. contact Edward J. Wright
-
4.1.3. prepared 04/06/96
4.2. product identification
- 4.2.1. trade name.............................................................................................................................................................
- 4.2.2. common name ....................... sequential compression pump
- 4.2.3. classification name Compressible Limb Sleeve (Class II) 21 CFR 870.5800
- 4.2.4. product number ................................................................................................. 74JQW
4.3. equivalence
- 4.3.1. The proposed device is similar in design, function, and composition to existing compression pump devices such as document K830577B (Wright Linear Pump gradient), document K871271 (Huntleigh / Flowpress AC300) pump, document K874688 (Huntleigh Flowtron AC 200/2), and document K921608 (Chattanooga Presssion sequential).
- 4.3.1.1. As a sequential pressure system, the proposed device is simpler than existing gradient pressure systems (Wright Linear Pump K830577B) for treating "simple lymphedema" or mild patient cases.
4.4. description
- 4.4.1. This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity.
- 4.4.2. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.
4.5. intended use
- 4.5.1. The proposed device is to be used to improve the return circulation
03 April 1996 01996 Wright Linear Pump, Inc. 510k Submission -- Sequential Compression Therapy Device
1
of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
- 4.5.2. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders.
- 4.5.3. Complies with physician-prescribed treatment pressures.
- section 513, 801(b), 52 Stat. 1055, 90 Stat. 540-546 (21 4.5.3.1. U.J.C. 360C 371(A)
4.6. technological characteristics
- 4.6.1. This device is a new state-of-the-art sequential compression pump/ and appliance system which produces better results than single-4 pressure systems currently in use.
- At end of the pressure phase of the treatment cycle, this 4.6.1.1. device disengages cells in quick succession, from proximal to distal, to ensure a reverse gradient is never applied despite any slight irregularities inherent in mechanical pneumatic systems. Cell C is disengaged just before cell B and, in turn. B iust before A.
- 4.6.2. The proposed device is factory-preset for a maximum pressure less than 101 mm Hg.
4.7. safety and effectiveness performance data
- 4.7.1. non-clinical test data
- 4.7.1.1. Cell pressures of prototype device were measured using separate precision regulators for each appliance cell.
- 4.7.1.2. Pressures in each cell reach the prescribed setting 10 or more seconds before the next cell is activated.
- 4.7.1.3. Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and, thus, sustained.
- 4.7.2. clinical test data
- 4.7.2.1. not applicable