FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG
K Number: K801719
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
11
Applicant Total
278
Review Days
11
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
- BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG
- K Number
- K801719
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1250
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Fred Sammons, Inc.
- Date Received
- July 24, 1980
- Decision Date
- August 4, 1980
- Product Code
- HRW
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HRW | Dynamometer, Nonpowered | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRW), ordered by most recent decision date.
JTECH COMMANDER AND ALGOMETER
FDA 510(k)
FDA Class 1
·Orthopedic
DIGIT-GRIP WITH LCD (DGR002)
FDA 510(k)
FDA Class 1
·Orthopedic
LIGHTSCOPE SET
FDA 510(k)
FDA Class 1
·Orthopedic
HANDHELD DYNAMOMETER, MODEL #160 AND #111
FDA 510(k)
FDA Class 1
·Orthopedic
PINCH GAUGE, 0-301 LBS.
FDA 510(k)
FDA Class 1
·Orthopedic
PINCH METER
FDA 510(k)
FDA Class 1
·Orthopedic
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 |