510(k) K950441

CONAIR FAMILY FITNESS BODY ENERGY by Conair Corp. — Product Code IRO

K950441 is an FDA 510(k) premarket notification submitted by Conair Corp. for the device "CONAIR FAMILY FITNESS BODY ENERGY". The FDA issued a decision of Substantially Equivalent on July 18, 1995. The device falls under product code IRO (Vibrator, Therapeutic), a Class I device regulated under 21 CFR 890.5975. Conair Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1995
Date Received
January 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vibrator, Therapeutic
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type