Atlas FDA

CRUTCH TIPS & GRIPS

FDA 510(k) clearance K810650 · decided 1981-03-26

Clearance details

K-number
K810650
Device name
CRUTCH TIPS & GRIPS
Applicant
First Industries, Inc.
Decision
Substantially Equivalent
Date received
1981-03-10
Decision date
1981-03-26
Days to decision
16 days
Clearance type
Traditional
Product code
INP
Device class
1
Regulation number
890.3790
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SURGEON'S CHOICE CRUTCH HANDLE (K831889)W.K. Wheeler, Inc.1983-07-07
PERSONAL KNEE CRUTCH PAD (K831149)Tecnol New Jersey Wound Care, Inc.1983-05-03
CRUTCH & WALKER PADS (K811493)Fred Sammons, Inc.1981-06-12
CONPHAR CRUTCH TIPS (K803136)Conphar, Inc.1981-01-08
CONPHAR CRUTCH GRIPS (K803140)Conphar, Inc.1981-01-08
CONPHAR CRUTCH PADS (K803144)Conphar, Inc.1981-01-08
CRUTCH TIPS, PADS & HAND GRIPS (K800076)New World Imports, Inc.1980-01-28

Recalls involving this device

No recalls on record reference this clearance.