FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HILTHERA 4.0
K Number: K141861
·
Decision Jan 7, 2015
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
15
Review Days
181
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Basic Information
- Device Name
- HILTHERA 4.0
- K Number
- K141861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeisys Medical, Inc.
- Date Received
- July 10, 2014
- Decision Date
- January 7, 2015
- Product Code
- ILY
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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