Duns Number:519969810
Device Description: Accurate measurements of upper and lower extremity ROM with precise electronic tools for e Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting.The Biometrics Range of Motion Kit (R500) provides precise electronic tools for:upper and lower extremity range of motion measurements
Catalog Number
-
Brand Name
E-LINK R500 ROM Kit (Range of Motion)
Version/Model Number
R500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
c806e7a7-4ebb-44f1-87b5-7e3d5abcfbc4
Public Version Date
June 11, 2018
Public Version Number
1
DI Record Publish Date
May 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |