| Device |
cold pack and vibrating massager |
| Regulation Description |
Therapeutic vibrator. |
| Definition |
Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture). |
| 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 Medical Specialty |
Physical Medicine |
| Review Panel |
Physical Medicine |
|---|
| Product Code | PHW |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
890.5975
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
