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510(k) K854193

ELECTRO-MYOGRAPHIC PERINEOMETER by Verimed Holdings, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
October 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Verimed Holdings, Inc.

  • K981277 — PERIFORM (November 20, 1998)
  • K954127 — BIOFEEDBACK DEVICE (November 14, 1995)
  • K951969 — MYOEXORCISER II FUAL (June 14, 1995)
  • K930670 — PHYACTION 787 (July 2, 1993)
  • K922550 — ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) (December 10, 1992)
  • K913912 — VERIMED PERINEOMETER (June 16, 1992)
  • K893220 — VERIMED MYOEXORCISER VERISTIM (March 7, 1990)
  • K892649 — VERIMED MYOEXORCISER III (MYO III) (December 13, 1989)
  • K874212 — VERIMED MYO/PREMS (August 8, 1988)
  • K852963 — MYO-ACTUATOR (January 21, 1986)

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  • K212655 — Flyte (September 21, 2021)
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  • K193364 — Intimate Rose Kegel Exercise System (August 24, 2020)