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510(k) K952043

BACK MASSAGER by Eight Corners, Inc. — Product Code LYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Manual
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type

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  • K903820 — THERA-CANE (September 19, 1990)
  • K884907 — BUMPY MEDICAL MASSAGE MAT (December 27, 1988)