Identity
- Trade Name
- Flexitouch FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Model / Reference
- L-CF-RG-L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816305020137 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-chamber venous compression system garment, reusable
Flexitouch by Tactile Systems Technology Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-chamber venous compression system garment, reusable.
- AIRCAST — DJO, LLC · Class II
- Lympha Press 8 3-65 L NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd · Class II
- Wright — Wright Therapy Products, Inc. · Class II
- CircuFlow — OAKWELL DISTRIBUTION, INC. · Class II
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD. · Class II
- Adult boot No. 2A RC-FLS — MEGO afek Agricultural Cooperative Society Ltd · Class II
- Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow - Black — BIO COMPRESSION SYSTEMS, INC. · Class II
- Bio Compression Systems 8 Chamber Arm & Shoulder Sleeve - Large — BIO COMPRESSION SYSTEMS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tactile Systems Technology Inc
Sources (1)
- FDA UDI db0f3427-2bc5-4bac-bce1-6dc594bf1d1d 32 fields · synced May 30, 2026