Cleared Traditional

PULSARII, HIGH VOLT. GALVANIC MUSC. STIM (K810064) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810064 · Bomed Medical Mfr., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
13d
Days
Class 2
Risk

K810064 is an FDA 510(k) clearance for the PULSARII, HIGH VOLT. GALVANIC MUSC. STIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bomed Medical Mfr., Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bomed Medical Mfr., Ltd. devices

Submission Details

510(k) Number K810064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date January 26, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 546
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K810064.
High Tone Power therapy (HiToP) (Model: HiToP PNP)
K252816 · Mohammadali Nezakati · Jun 2026
StimelMD (SSMD) system
K260142 · Motion Informatics ltd. · May 2026
Compact II
K251083 · Enraf-Nonius, B.V. · Sep 2025
EVE Synergy (EVE-20M)
K241433 · Weero Co., Ltd. · Jun 2025
TrainFES Advance
K241488 · Trainfes · Feb 2025
Quantum Mitohormesis (QMT) (M2101)
K240348 · Quantumtx Pte. , Ltd. · Dec 2024