510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HRWClass I

Dynamometer, Nonpowered

21 CFR 888.1250 / Orthopedic
FDA source (opens on fda.gov)

HRW is the FDA product code for Dynamometer, Nonpowered, a class I device type, regulated under 21 CFR 888.1250. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HRW
Device name
Dynamometer, Nonpowered
Regulation
21 CFR 888.1250
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
0

Clearances, product code HRW

By decision year
12 clearances under product code HRW with a decision year between 1977 and 1998, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HRW by decision year
YearClearances
19771
19782
19792
19801
19811
19821
19861
19891
19971
19981

Applicants with the most clearances

Product code HRW
Applicants holding the most 510(k) clearances under product code HRW
ApplicantClearances
Fred Sammons, Inc.6
J-Tech Medical, Inc.1
Nk Biotechnical Corp.1
Optik1
Spark Instruments & Academics, Inc.1
The Orthodyn Co.1
Zatek1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order