FDA Registration
Active
🇺🇸 United States
CircuFlow Large Wide Leg Sleeve (D-300LW)
Reg #: 3014491159
·
FEI: 3014491159
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- AIROS MEDICAL INC
- Registration Number
- 3014491159
- FEI Number
- 3014491159
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2501 MONROE BLVD STE 1200
- City
- Audubon
- State
- PA
- ZIP
- 19403
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100446
Owner / Operator
- Firm Name
- AIROS Medical, Inc.
- Operator Number
- 10058005
- Address
- 2501 Monroe Blvd, Suite 1200
- City
- Audubon
- State
- PA
- Postal Code
- 19403
- Country
- US
- Correspondent
- Darren Behuniak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2018-10-24 |
Proprietary Names
CircuFlow Large Wide Leg Sleeve (D-300LW)
CircuFlow Half Wide Leg Sleeve (D-301HW)
CircuFlow Medium Arm Sleeve (D-302M)
CircuFlow 5100 Sequential Compression Device
CircuFlow Small Wide Leg Sleeve (D-300SW)
CircuFlow Large Arm Sleeve (D-302L)
CircuFlow Medium Wide Leg Sleeve (D-300MW)
CircuFlow Small Leg Sleeve (D-300S)
Circuflow Large Leg Sleeve (D-300L)
CircuFlow Medium Leg Sleeve (D-300M)
Circuflow Medium Extra Wide Leg Sleeve (D-300MXW)
CircuFlow Half Leg Sleeve (D-301H)
CircuFlow Small Extra Wide Leg Sleeve (D-300SXW)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device