Identity
- Trade Name
- Nimbl FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- Full Leg Extender, Long FDA UDI
- Model / Reference
- PL-EX-LO-LR FDA UDI
- Description
- Full Leg Extender, Long FDA UDI
Identifiers
- Catalog Number
- 704005-001 FDA UDI
- Primary DI / UDI-DI
- 00816305024999 FDA UDI
- 510(k) Number
- K234155 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-chamber venous compression system garment, reusable
Nimbl 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
Cleared under the same submission
K234155 also covers:
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
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 93d9f123-ea5d-4a6f-a205-60bc32a7073e 36 fields · synced Jun 7, 2026