Duns Number:429763668
Device Description: The configuration is composed of an electrostimulator and other components, useful for rec The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it.The SPM01M1 configuration supports Bluetooth Low Energy communication. In this case it can connect directly to a smartphone/tablet on which a dedicated app is installed. The dedicated control software is supplied via an usb receiver and must be used by a properly trained healthcare professional.
Catalog Number
SPM01M1
Brand Name
Shoulder Pacemaker device
Version/Model Number
SPM01M1
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K210674
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
8fb8f02f-3f33-464c-82a4-db87baecc79a
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |