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510(k) K102051

PAIN BUDDY by Biomedical Life Systems, Inc. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2011
Date Received
July 21, 2010
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.

  • K172971 — BMLS16-1 (July 8, 2018)
  • 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

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  • 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)