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510(k) K132949

PELLEFIRM by Ellman International, Inc. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2014
Date Received
September 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Radio Frequency Induced Heat
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

Other clearances by Ellman International, Inc.

  • K132665 — PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC (September 25, 2013)
  • K123366 — SURGITRON 4.0 DUAL RF S5-IEC (July 12, 2013)
  • K071343 — ELLMAN NOBLE ALLOY ELECTRODES (February 28, 2008)
  • K052241 — DISC-FX SYSTEM (February 24, 2006)

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