Home / 510(k) Clearances / K172971

510(k) K172971

BMLS16-1 by Biomedical Life Systems, Inc. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2018
Date Received
September 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Biomedical Life Systems, Inc.

  • 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)
  • K040306 — HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 (March 23, 2004)
  • K033455 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 (January 15, 2004)
  • K031427 — ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 (August 19, 2003)

Other clearances for product code NUH

  • K253896 — TENS/EMS device (GUSE01) (March 4, 2026)
  • K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (December 31, 2025)
  • K251958 — VEINOPLUS Back (December 23, 2025)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (November 24, 2025)
  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K243131 — Triathlon Pro (November 7, 2025)
  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)