Hello Glenn,
Thanks for the reply. I read through your explanation and I'm curious about as couple of things -
First, in regards to the PowerStrips being a class 1 medical device - as far as I know, and from researching, any form of applicable bandage is is a class 1 medical device and is exempt from the usual testing the FDA requires.
Second, can you clarify about the Waveform aspect of the PowerStrips - is this similar to the holographic energy patches from Lifewave and CieAura?
Device
dressing, compression
Regulation Description
Elastic bandage.
Regulation Medical Specialty
General Hospital
Review Panel
General & Plastic Surgery
Product Code
MHW
Premarket Review
Office of Device Evaluation 6(ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools (PRSB1)
Submission Type
510(K) Exempt
Regulation Number
880.50757
Device Class
1
Total Product Life Cycle (TPLC)
TPLC Product Code Report8
GMP Exempt?
No
Note: FDA has exempted almost all class I devices (with the exception of
reserved devices9) 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 862-89210. 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 862-89211, 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 website12 for additional information.
Third Party Review
Not Third Party Eligible