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510(k) K801053

PULSED GALVANIC STIMULATOR, 450-DYNAMAX by U.S. Medical Corp. — Product Code IPF

K801053 is an FDA 510(k) premarket notification submitted by U.S. Medical Corp. for the device "PULSED GALVANIC STIMULATOR, 450-DYNAMAX". The FDA issued a decision of Substantially Equivalent on June 4, 1980. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. U.S. Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1980
Date Received
May 5, 1980
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 U.S. Medical Corp.

  • K934677 — U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE (July 5, 1994)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K924441 — U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (February 12, 1993)
  • K910583 — U.S. MEDICAL PS-3000 NEONATAL SCALE (March 21, 1991)
  • K910582 — U.S. MEDICAL PS-2000 PEDIATRIC SCALE (March 21, 1991)
  • K910581 — U.S. MEDICAL PS-1000 PEDIATRIC SCALE (March 21, 1991)
  • K896633 — AUTO-CUFF(TM) (February 1, 1990)

Other clearances for product code IPF

  • K253542 — Apollo Quattro (APQ-10M) (June 8, 2026)
  • K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP) (June 2, 2026)
  • K260142 — StimelMD (SSMD) system (May 27, 2026)
  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)

FDA data resources