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510(k) K981969

ULTIMA BODY POSITION SENSOR by Braebon Medical Corp. — Product Code LEL

K981969 is an FDA 510(k) premarket notification submitted by Braebon Medical Corp. for the device "ULTIMA BODY POSITION SENSOR". The FDA issued a decision of Substantially Equivalent on August 20, 1998. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Braebon Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1998
Date Received
June 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Braebon Medical Corp.

  • K061764 — MEDIBYTE, MODEL MP8 (September 6, 2006)
  • K031202 — MEDIPALM-20 (May 1, 2003)
  • K020312 — ULTIMA SNORING MIKE, MODEL 0540 (August 7, 2002)
  • K001743 — ULTIMA SMARTBELT, MODEL 0560 (August 25, 2000)
  • K984431 — ULTIMA AIRFLOW PRESSURE SENSOR (December 30, 1998)
  • K981445 — ULTIMA AIRFLOW SENSOR, 0510 (October 5, 1998)
  • K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 (September 11, 1998)

Other clearances for product code LEL

  • K252981 — EmbraceMini (December 22, 2025)
  • K251574 — Sleep Watch (July 31, 2025)
  • K243513 — DCM (PW-DCM) (April 16, 2025)
  • K233987 — VERABAND™ (June 17, 2024)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)

FDA data resources