| Device Type ID | 5166 |
| Device Name | Massager, Powered Inflatable Tube |
| Regulation Description | Powered Inflatable Tube Massager. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.5650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IRP |
| 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 | 5166 |
| Device | Massager, Powered Inflatable Tube |
| Product Code | IRP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Inflatable Tube Massager. |
| CFR Regulation Number | 890.5650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DAESUNG MAREF CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAXSTAR INDUSTRIAL CO. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEGO AFEK AC LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NORMATEC INDUSTRIES, LP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PORTABLE THERAPEUTIX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Auto Stop | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Won Industry Co. | II | Dec-06-2017 |