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510(k) K180173

Freespira by Palo Alto Health Sciences, Inc. — Product Code HCC

K180173 is an FDA 510(k) premarket notification submitted by Palo Alto Health Sciences, Inc. for the device "Freespira". The FDA issued a decision of Substantially Equivalent on August 23, 2018. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Palo Alto Health Sciences, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2018
Date Received
January 22, 2018
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 Palo Alto Health Sciences, Inc.

  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • 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)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

FDA data resources