FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RICH-MAR SPINA-MOBILIZOR
K Number: K861832
·
Decision Jun 27, 1986
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
69
Applicant Total
43
Review Days
45
Basic Information
- Device Name
- RICH-MAR SPINA-MOBILIZOR
- K Number
- K861832
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- RICH-MAR CORP.
- Date Received
- May 13, 1986
- Decision Date
- June 27, 1986
- Product Code
- ITH
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| ITH | Equipment, Traction, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITH), ordered by most recent decision date.
DRX9000C-SL Cervical Spinal Decompression System
FDA 510(k)
FDA Class 2
·Physical Medicine
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
FDA 510(k)
FDA Class 2
·Physical Medicine
c1Trac
FDA 510(k)
FDA Class 2
·Physical Medicine
ELTRAC 471
FDA 510(k)
FDA Class 2
·Physical Medicine
Modpod
FDA 510(k)
FDA Class 2
·Physical Medicine
ITRAC CERVICAL TRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by RICH-MAR CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K040679 | RICH-MAR AUTOPRISM INFRARED LAMP | May 7, 2004 | Substantially Equivalent |
| K031018 | AUTOGEL PAD | Dec 8, 2003 | Substantially Equivalent |
| K032941 | AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Oct 22, 2003 | Substantially Equivalent |
| K021483 | RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND | Sep 13, 2002 | Substantially Equivalent |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Jan 18, 2002 | Substantially Equivalent |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | Jan 18, 2002 | Substantially Equivalent |
| K012848 | WINNER CM4 COMBINATION UNIT | Oct 25, 2001 | Substantially Equivalent |
| K000808 | RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE | Aug 25, 2000 | Substantially Equivalent |
| K982544 | RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES | Nov 19, 1998 | Substantially Equivalent |
| K952089 | RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE | Aug 11, 1995 | Substantially Equivalent for Some Indications |