Compression Devices, Limb
510(k) K781964
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781964 | Date12 Dec 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IRP
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Powered Inflatable Tube Massager, classified as a Class II medical device under FDA regulations. It is designed to apply controlled compression to limbs, promoting circulation and reducing swelling or edema. The inflatable tubes are intended for use in physical medicine applications, such as preventing deep vein thrombosis (DVT) or aiding in lymphatic drainage.
The device is supplied as a reusable, non-sterile system and is intended for use in clinical or home settings. It operates via an inflatable mechanism, typically powered by an external air source, and is regulated under FDA 510(k) clearance (K781964) with a traditional review process. No MRI safety information or specific sterility requirements beyond non-sterile use are indicated in the data. The device was authorized under the regulation number 890.5650 and falls under the IRP product code.
Other devices from Alba-Waldensian, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Powered Inflatable Tube Massager designed for?
The Powered Inflatable Tube Massager is designed to apply controlled compression to limbs, promoting circulation and reducing swelling or edema. It is particularly useful in physical medicine applications, such as preventing deep vein thrombosis (DVT) or assisting with lymphatic drainage. The device achieves this through inflatable tubes powered by an external air source.
Is the Powered Inflatable Tube Massager reusable or single-use?
This device is supplied as a reusable system. It is intended for use in both clinical and home settings, meaning it can be used repeatedly after proper cleaning and maintenance, rather than being discarded after a single use.
What are the sterility requirements for the Powered Inflatable Tube Massager?
The Powered Inflatable Tube Massager is classified as a non-sterile device. This means it is not pre-sterilized and should not be used in procedures requiring sterile conditions unless additional sterilization is performed by the user prior to use.
What types of models or sizes are available for the Powered Inflatable Tube Massager?
Multiple models and registration numbers are associated with this device, indicating a range of variations in size and configuration. These include registration numbers like 3012184077, 3027321925, and others listed under the OpenFDA data. These variations likely correspond to different limb sizes or specific compression requirements, allowing for tailored use in various clinical or home settings.
How should the Powered Inflatable Tube Massager be stored?
While specific storage instructions are not detailed in the provided data, reusable medical devices like this typically require storage in a clean, dry environment to prevent contamination and ensure longevity. It is important to follow manufacturer guidelines for cleaning and maintenance to maintain functionality and hygiene, especially since it is intended for repeated use.