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510(k) K954127

BIOFEEDBACK DEVICE by Verimed Holdings, Inc. — Product Code HCC

K954127 is an FDA 510(k) premarket notification submitted by Verimed Holdings, Inc. for the device "BIOFEEDBACK DEVICE". The FDA issued a decision of Substantially Equivalent on November 14, 1995. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Verimed Holdings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1995
Date Received
August 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Verimed Holdings, Inc.

  • K981277 — PERIFORM (November 20, 1998)
  • 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)
  • K854193 — ELECTRO-MYOGRAPHIC PERINEOMETER (June 9, 1986)
  • K852963 — MYO-ACTUATOR (January 21, 1986)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)

FDA data resources