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510(k) K882139

2P-QDA FOOT PRESSURE SYSTEMS REAL TIME by Human Performance Technologies, Inc. — Product Code JFC

K882139 is an FDA 510(k) premarket notification submitted by Human Performance Technologies, Inc. for the device "2P-QDA FOOT PRESSURE SYSTEMS REAL TIME". The FDA issued a decision of Substantially Equivalent on June 22, 1988. The device falls under product code JFC (System, Pressure Measurement, Intermittent), a Class I device regulated under 21 CFR 890.1600. Human Performance Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1988
Date Received
May 23, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Pressure Measurement, Intermittent
Device Class
Class I
Regulation Number
890.1600
Review Panel
PM
Submission Type

Other clearances by Human Performance Technologies, Inc.

  • K880631 — 2K-QDA MOTION/GAIT ANALYSIS SYSTEM (April 21, 1988)

Other clearances for product code JFC

  • K924705 — FORCE SENSING ARRAY (May 12, 1993)
  • K925258 — DYNAMIC PRESSURE MONITOR 2000M AND 2000C (March 9, 1993)
  • K925052 — QA PRESSURE MEASUREMENT SYSTEM (March 9, 1993)
  • K915278 — CDG GAIT ANALYSES SYSTEM (April 7, 1992)
  • K914776 — OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR (December 19, 1991)
  • K913510 — MECHANICAL SHAPE SENSOR (September 23, 1991)
  • K881284 — COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE (July 21, 1988)
  • K861260 — PEDABAROGRAPH (May 2, 1986)
  • K831800 — TEXAS INTERFACE PRESSURE EVALUATOR-TIPE (August 16, 1983)
  • K823681 — MODEL ICPM & ACCESSORIES (February 23, 1983)

FDA data resources