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510(k) K040306

HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 by Biomedical Life Systems, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2004
Date Received
February 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Biomedical Life Systems, Inc.

  • K172971 — BMLS16-1 (July 8, 2018)
  • K102051 — PAIN BUDDY (July 29, 2011)
  • K061476 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 (July 26, 2006)
  • K042711 — MODEL BMLS03-7 (March 14, 2005)
  • K041388 — COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, (November 23, 2004)
  • K040007 — INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 (July 7, 2004)
  • K033174 — BMLS03-3 (June 30, 2004)
  • K040824 — INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 (April 29, 2004)
  • K033455 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 (January 15, 2004)
  • K031427 — ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 (August 19, 2003)

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  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
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