Cleared Traditional

K980958 - HAKOMED ELECDT/VACUPULLS

K980958 is an FDA 510(k) clearance for HAKOMED ELECDT/VACUPULLS, manufactured by Alive, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K980958 · Alive, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
56d
Days
Class 2
Risk

K980958 is an FDA 510(k) clearance for the HAKOMED ELECDT/VACUPULLS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Alive, Inc. (Honolulu, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 56 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 Alive, Inc. devices

FDA 510(k) Submission Details - K980958

510(k) Number K980958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date May 11, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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 196
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K980958.
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
K980040 · Nisha Communication Industries · Jul 1998
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
K973929 · Neotonus, Inc. · May 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · Alive, Inc. · May 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · Universal Technology Systems, Inc. · Apr 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
STELLAR MODEL HS-04
K973223 · Stellar Medical Corp. · Feb 1998