Cleared Traditional

K982607 - MANUAL WHEELCHAIR

K982607 is an FDA 510(k) clearance for MANUAL WHEELCHAIR, manufactured by G. Hirsch and Co., Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K982607 · G. Hirsch and Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
35d
Days
Class 1
Risk

K982607 is an FDA 510(k) clearance for the MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by G. Hirsch and Co., Inc. (Burlingame, US). The FDA issued a Cleared decision on August 31, 1998 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 G. Hirsch and Co., Inc. devices

FDA 510(k) Submission Details - K982607

510(k) Number K982607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date August 31, 1998
Days to Decision 35 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 138
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K982607.
MOMENTUM NO. FS008 WHEELCHAIR
K982099 · Sriram Enterprises D.B.A. Momentum Group · Oct 1998
PANTHER WHEELCHAIR
K982849 · Snug Seat, Inc. · Oct 1998
QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR
K982989 · Sunrise Medical, Inc. · Oct 1998
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
K982336 · Invacare Corp. · Aug 1998
MYCYCLE, HANDMASTER, VICTORY
K981557 · Richvale , Ltd. · Jul 1998
MYCYCLE HANDMASTER, LIGHT
K981558 · Richvale , Ltd. · Jul 1998