Air Compression Leg Massager (Models S9036C, S9036B, S9036A)
by Shenzhen Dongjilian Medical Tech Co., Ltd
510(k) K222206
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222206 | Date30 Sep 2022 | 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- Withdrawn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
- Full name
- Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
- 510(k) Number
- FDA Product Code
- IRP
- FDA applicant
- Shenzhen Dongjilian Medical Tech Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Air Compression Leg Massager (Models S9036C, S9036B, S9036A) is a Powered Inflatable Tube Massager, designed to provide intermittent pneumatic compression therapy to the legs. It uses controlled air pressure cycles to promote circulation, reduce swelling, and alleviate discomfort in the lower extremities.
This device is intended for use in clinical and home settings, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K222206) as a Class II device (IRP product code) and adheres to regulation 890.5650. No MRI safety or sterility specifications are noted in the regulatory data.
Other devices from Shenzhen Dongjilian Medical Tech Co., Ltd
Questions
AI-generated answers, 19 Sep 2026
What are the key differences between the S9036A, S9036B, and S9036C models of the Air Compression Leg Massager?
The provided data does not specify any technical, functional, or design differences between the S9036A, S9036B, and S9036C models. All three models are listed as the same device—an Air Compression Leg Massager—with identical regulatory filings and product codes. If you require model-specific details (e.g., pressure settings, tube sizes, or additional features), they are not included in the available documentation.
Is this device intended for single-use or reusable applications?
The Air Compression Leg Massager is explicitly described as a reusable medical instrument, suitable for both clinical and home use. Since it is not classified as a single-use device, it should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene.
How is the regulatory status of this device determined?
This device holds FDA 510(k) clearance (K222206) under the classification of a Class II medical device, specifically categorized under the IRP (Inflatable Pressure) product code and regulated by 21 CFR 890.5650. The clearance was granted through a traditional 510(k) review process by the FDA’s Physical Medicine (PM) Advisory Committee, confirming it is substantially equivalent to a predicate device.
What types of settings or environments is this device designed for?
The Air Compression Leg Massager is designed for use in both clinical and home settings, providing intermittent pneumatic compression therapy to promote circulation, reduce swelling, and alleviate discomfort in the lower extremities. Its reusable nature makes it versatile for shared use in healthcare facilities or individual use at home.
Are there any special considerations for storage or maintenance of this device?
The provided data does not specify storage conditions or maintenance requirements beyond its classification as a reusable medical instrument. For optimal performance and longevity, it is recommended to follow the manufacturer’s guidelines for cleaning, disinfection, and proper storage—particularly if used in clinical settings where hygiene is critical. Since no sterility specifications are noted, it is not intended for sterile procedures.