| Device Type ID | 845 |
| Device Name | Sleeve, Limb, Compressible |
| Regulation Description | Compressible Limb Sleeve. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JOW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 845 |
| Device | Sleeve, Limb, Compressible |
| Product Code | JOW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Compressible Limb Sleeve. |
| CFR Regulation Number | 870.5800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACI MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALBAHEALTH LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARJOHUNTLEIGH AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARJOHUNTLEIGH POLSKA SP Z.O.O. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO COMPRESSION SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
BIO COMPRESSION SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CAREMED SUPPLY INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CURRIE MEDICAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DAESUNG MAREF CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEVON MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEVON MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DEVON MEDICAL PRODUCTS (JIANGSU) LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HEALTHCARE SERVICE AND SUPPLY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INNOVAMED HEALTH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDI USA, LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEGO AFEK AC LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MILKA, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NORMATEC INDUSTRIES, LP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RECOVERY FORCE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TACTILE SYSTEMS TECHNOLOGY INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILDCAT MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WUHAN LANDING MEDICAL HI-TECH LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Temperature Problem | 46 |
Power Cord | 45 |
Cut In Material | 42 |
Split | 39 |
Break | 33 |
Thermal Decomposition Of Device | 31 |
Adverse Event Without Identified Device Or Use Problem | 30 |
Wire | 24 |
Electrical /Electronic Property Problem | 23 |
Improper Flow Or Infusion | 22 |
Power Problem | 19 |
Infusion Or Flow Problem | 18 |
Scratched Material | 18 |
Electrical Wire | 14 |
Use Of Device Problem | 10 |
Appropriate Term/Code Not Available | 10 |
Insufficient Information | 6 |
Smoking | 5 |
Device Displays Incorrect Message | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Fire | 3 |
Sparking | 3 |
Charred | 3 |
Power Switch | 3 |
Device Damaged By Another Device | 3 |
Pumping Problem | 2 |
Patient Device Interaction Problem | 2 |
Plug | 2 |
Detachment Of Device Component | 2 |
Arcing | 2 |
Disconnection | 2 |
Electro-Static Discharge | 2 |
Pin | 2 |
Electromagnetic Compatibility Problem | 2 |
Cord | 2 |
Deflation Problem | 1 |
Degraded | 1 |
No Display / Image | 1 |
Melted | 1 |
Material Split, Cut Or Torn | 1 |
Component Missing | 1 |
Delamination | 1 |
Unit | 1 |
Electrical Power Problem | 1 |
Flare Or Flash | 1 |
Device Operates Differently Than Expected | 1 |
Device Damaged Prior To Use | 1 |
Alarm | 1 |
Alarm, Audible | 1 |
Housing | 1 |
Failure To Run On AC/DC | 1 |
Display | 1 |
Detachment Of Device Or Device Component | 1 |
Torn Material | 1 |
Pressure Problem | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fuse | 1 |
Failure To Power Up | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 504 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arjo, Inc. Dba ArjoHuntleigh | II | Jun-26-2017 |
| 2 | COVIDIEN LLC | II | Mar-22-2019 |
| 3 | Stryker Sustainability Solutions | II | Dec-21-2017 |