Definition: Relief Of Minor Aches And Pains, Controlling The Pain Associated With Needle Sticks (injections, IV, Venipuncture).
| Device Type ID | 5241 |
| Device Name | Cold Pack And Vibrating Massager |
| Physical State | Cold Pack With Vibrating Massager |
| Technical Method | Combines A Cold Pack With Therapeutic Massage To Provide Vibrating Cold Therapy |
| Target Area | Applied To The Skin On Various Parts Of The Body |
| Regulation Description | Therapeutic Vibrator. |
| 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) Exempt |
| CFR Regulation Number | 890.5975 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PHW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5241 |
| Device | Cold Pack And Vibrating Massager |
| Product Code | PHW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Therapeutic Vibrator. |
| CFR Regulation Number | 890.5975 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MMJ LABS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |