FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMOLATOR HEATING UNIT
K Number: K801625
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
6
Applicant Total
3
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
- THERMOLATOR HEATING UNIT
- K Number
- K801625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Tru-Eze Mfg. Co., Inc.
- Date Received
- July 15, 1980
- Decision Date
- July 28, 1980
- Product Code
- IRQ
- 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 |
|---|---|---|---|
| IRQ | Unit, Heating, Powered | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IRQ), ordered by most recent decision date.
EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
FDA 510(k)
FDA Class 1
·Physical Medicine
THEMALATOR. MODELS T-4-S, T-8-S, ETC.
FDA 510(k)
FDA Class 1
·Physical Medicine
FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917
FDA 510(k)
FDA Class 1
·Physical Medicine
ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)
FDA 510(k)
FDA Class 1
·Physical Medicine
R1750 AND R1424 POWERED HEATING UNITS
FDA 510(k)
FDA Class 1
·Physical Medicine
PULSAIR MODEL SP-1
FDA 510(k)
FDA Class 1
·Physical Medicine