FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIBRACARE
K Number: K870939
·
Decision Apr 6, 1987
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
9
Review Days
28
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
- VIBRACARE
- K Number
- K870939
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- General Physiotherapy, Inc.
- Date Received
- March 9, 1987
- Decision Date
- April 6, 1987
- Product Code
- ISA
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ISA), ordered by most recent decision date.
VMAT PRO
FDA 510(k)
FDA Class 1
·Physical Medicine
ShockPhysio Mobile (model SW3200 Basic)
FDA 510(k)
FDA Class 1
·Physical Medicine
BTL-094
FDA 510(k)
FDA Class 1
·Physical Medicine
Omnispec ED1000
FDA 510(k)
FDA Class 1
·Physical Medicine
OW100S (model OW100S-US)
FDA 510(k)
FDA Class 1
·Physical Medicine
DolorClast Radial
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by General Physiotherapy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863383 | FACIAL MASSAGER, BATTERY POWERED | Sep 15, 1986 | Substantially Equivalent |
| K861834 | THERACUSHION MODEL 1000 | May 27, 1986 | Substantially Equivalent |
| K855129 | NEOCUSSOR (MASSAGER, BATTERY) POWERED | Jan 23, 1986 | Substantially Equivalent |
| K853710 | THERACUSHION | Jan 3, 1986 | Substantially Equivalent |
| K852944 | FLEXIMATIC MASSAGER | Sep 5, 1985 | Substantially Equivalent |
| K850047 | SANYO ELECTRONIC MUSCLE STIMULATORS | Mar 5, 1985 | Substantially Equivalent |
| K844591 | MIST-EASE NEBULIZER | Dec 13, 1984 | Substantially Equivalent |
| K810244 | PORTA-PULS MUSCLE STIMULATOR | Feb 26, 1981 | Substantially Equivalent |