DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM


Device Classification Name

ultrasonic diathermy for use in applying therapeutic deep heat

510(k) Number K024307
Device Name DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
Original Applicant
SYBARITIC, INC.
9220 james ave. south
bloomington, 
MN 
55431

Original Contact randall e berglund
Regulation Number 890.5300
Classification Product Code
IMI  
Subsequent Product Code
ISA  
Date Received 12/24/2002
Decision Date 07/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls