Home / 510(k) Clearances / K020399

510(k) K020399

RESPERATE; MODEL RR-150 by Intercure , Ltd. — Product Code HCC

K020399 is an FDA 510(k) premarket notification submitted by Intercure , Ltd. for the device "RESPERATE; MODEL RR-150". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Intercure , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
February 6, 2002
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 Intercure , Ltd.

  • K000405 — INTERCURE LTD. RESPI-LOW (May 17, 2000)

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