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510(k) K992874

Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM by Wr Medical Electronics Co. — Product Code KTB

K992874 is an FDA 510(k) premarket notification submitted by Wr Medical Electronics Co. for the device "Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 18, 1999. The device falls under product code KTB (Device, Iontophoresis, Specific Uses), a Class II device regulated under 21 CFR 890.5525. Wr Medical Electronics Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1999
Date Received
August 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances by Wr Medical Electronics Co.

  • K092809 — HRV ACQUIRE (October 19, 2010)
  • K063560 — HILGER DUAL-STIM NERVE STIMULATOR (January 5, 2007)
  • K000574 — IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) (August 9, 2000)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K895838 — BRACKMANN EMG MONITORING SYSTEM (March 27, 1990)

Other clearances for product code KTB

  • K180627 — Macroduct Advanced Model 3710 (July 27, 2018)
  • K033192 — RH-950 (December 22, 2003)
  • K031551 — NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) (August 20, 2003)
  • K031115 — RH-900 (July 10, 2003)
  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K895775 — CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM (April 23, 1990)

FDA data resources