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510(k) K862121

E.W.L. P-TENS/H-WAVE by Electronic Waveform Laboratory, Inc. — Product Code KZM

K862121 is an FDA 510(k) premarket notification submitted by Electronic Waveform Laboratory, Inc. for the device "E.W.L. P-TENS/H-WAVE". The FDA issued a decision of Substantially Equivalent on June 17, 1987. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. Electronic Waveform Laboratory, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1987
Date Received
June 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Muscle Monitoring
Device Class
Class II
Regulation Number
890.1375
Review Panel
DE
Submission Type

Other clearances by Electronic Waveform Laboratory, Inc.

  • K103738 — H-WAVE (June 1, 2011)
  • K081998 — H-WAVE SPORT (July 9, 2009)
  • K915230 — H WAVE MUSCLE STIMULATOR (May 8, 1992)
  • K873604 — E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY (April 12, 1988)
  • K813601 — E.W.L. P-TENS MODEL(TENS (March 19, 1982)

Other clearances for product code KZM

  • K161716 — TEETHAN 2.0 (December 21, 2016)
  • K130158 — M-SCAN (July 25, 2013)
  • K113677 — GRINDCARE MEASURE (April 5, 2012)
  • K082927 — BIOEMG III (February 6, 2009)
  • K043373 — DOLOTENS DENTAL TM 1 (September 2, 2005)
  • K030869 — BITESTRIP (May 14, 2004)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (September 10, 1999)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)

FDA data resources