Cleared Traditional

K853154 - HV-4

K853154 is an FDA 510(k) clearance for HV-4, manufactured by Robert Bosch Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K853154 · Robert Bosch Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
242d
Days
Class 2
Risk

K853154 is an FDA 510(k) clearance for the HV-4. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Robert Bosch Corp. (St. James, US). The FDA issued a Cleared decision on March 28, 1986 after a review of 242 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Robert Bosch Corp. devices

FDA 510(k) Submission Details - K853154

510(k) Number K853154 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 29, 1985
Decision Date March 28, 1986
Days to Decision 242 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 115d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

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 272
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K853154.
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · Empi · Dec 1986
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986
RICH-MAR IF 200
K854485 · Rich-Mar Corp. · Jun 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249 · Mettler Electronics Corp. · Mar 1986
SYS*STIM 206 (MODEL-ME 206)
K860107 · Mettler Electronics Corp. · Mar 1986
EMPI MODEL 720 NMS
K854774 · Empi · Feb 1986