FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC

K Number: K862468 · Decision Jul 10, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
44
Applicant Total
43
Review Days
10

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
K Number
K862468
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5290
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Rich-Mar Corp.
Date Received
June 30, 1986
Decision Date
July 10, 1986
Product Code
IMJ
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (IMJ), ordered by most recent decision date.

View all

Other Clearances by Rich-Mar Corp.

K Number Device Name
K040679 RICH-MAR AUTOPRISM INFRARED LAMP
K031018 AUTOGEL PAD
K032941 AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K021483 RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K013770 MODIFICATION TO: WINNER ST-2 STIMULATOR
K013771 MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K012848 WINNER CM4 COMBINATION UNIT
K000808 RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K982544 RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K952089 RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
Search all 43 clearances from Rich-Mar Corp. →