FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K Number: K884255
·
Decision Nov 8, 1988
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
83
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
- CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
- K Number
- K884255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- October 11, 1988
- Decision Date
- November 8, 1988
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILO), ordered by most recent decision date.
Armory Motion
FDA 510(k)
FDA Class 2
·Physical Medicine
COOLSKIN
FDA 510(k)
FDA Class 2
·Physical Medicine
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
FDA 510(k)
FDA Class 2
·Physical Medicine
JUNIPER CLN1 DERMAL COOLING DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO POLAR CARE 500
FDA 510(k)
FDA Class 2
·Physical Medicine
IVC SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Concept, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | May 1, 1992 | Substantially Equivalent |
| K912957 | CONCEPT MICROMILL | Oct 4, 1991 | Substantially Equivalent |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K882121 | C-FLO SUCTION TUBE | Jun 20, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |
| K874676 | INTERFERENCE SCREW | Mar 7, 1988 | Substantially Equivalent |