FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
K Number: K963561
·
Decision Nov 21, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
21
Review Days
77
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
- ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
- K Number
- K963561
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tecnol Medical Products, Inc.
- Date Received
- September 5, 1996
- Decision Date
- November 21, 1996
- Product Code
- FMQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMQ), ordered by most recent decision date.
PROTECTIVE RESTRAINT
FDA 510(k)
FDA Class 1
·General Hospital
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
FDA 510(k)
FDA Class 1
·General Hospital
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
FDA 510(k)
FDA Class 1
·General Hospital
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
FDA 510(k)
FDA Class 1
·General Hospital
INFANT LIMB HOLDER, MODELS 306080 & 306081
FDA 510(k)
FDA Class 1
·General Hospital
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Tecnol Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974068 | PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL | Dec 22, 1997 | Substantially Equivalent |
| K970448 | PCM 2000; ISOLAIR APR MODEL 2735 | Apr 30, 1997 | Substantially Equivalent |
| K963559 | WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) | Nov 22, 1996 | Substantially Equivalent |
| K963564 | PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) | Nov 22, 1996 | Substantially Equivalent |
| K963552 | QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) | Nov 22, 1996 | Substantially Equivalent |
| K963773 | 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT | Nov 21, 1996 | Substantially Equivalent |
| K963563 | ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) | Nov 21, 1996 | Substantially Equivalent |
| K963556 | SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) | Nov 21, 1996 | Substantially Equivalent |
| K963554 | 24448-010 SECURE-ALL FINGER CONTROL MITT | Nov 21, 1996 | Substantially Equivalent |
| K963557 | SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 | Nov 21, 1996 | Substantially Equivalent |