FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGIC CUSHION MASSAGER
K Number: K810447
·
Decision Mar 4, 1981
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
278
Review Days
13
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
- MAGIC CUSHION MASSAGER
- K Number
- K810447
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- February 19, 1981
- Decision Date
- March 4, 1981
- 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 Fred Sammons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | May 6, 1988 | Substantially Equivalent |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Apr 1, 1988 | Substantially Equivalent |
| K831549 | ARM SLINGS | Jun 30, 1983 | Substantially Equivalent |
| K831548 | SPLINTS | Jun 27, 1983 | Substantially Equivalent |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Jun 24, 1983 | Substantially Equivalent |
| K831550 | FINGER BONIOMETER BK7506 | Jun 24, 1983 | Substantially Equivalent |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Jun 24, 1983 | Substantially Equivalent |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Jun 24, 1983 | Substantially Equivalent |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Jun 16, 1983 | Substantially Equivalent |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Jun 8, 1983 | Substantially Equivalent |