PINSCO, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electromyograph, Diagnostic (IKN) (5) Dynamometer, Nonpowered (HRW) (4)

Premarket Exempt

No Yes

Clear

B&L Engineering Pinch Gauge - 00855144007008 Catalog Number :

Device Description : 0 to 60 lb Pinch Gauge

Device Class : 1

Duns Number: 079605952

Premarket Exempt : Yes

Product Code : HRW

Prescription Use : No

Device Count : 1

B&L Engineering Pinch Gauge - 00855144007015 Catalog Number :

Device Description : 0 to 30 lb Pinch Gauge

Device Class : 1

Duns Number: 079605952

Premarket Exempt : Yes

Product Code : HRW

Prescription Use : No

Device Count : 1

B&L Engineering Pinch Gauge - 00855144007022 Catalog Number :

Device Description : 0 to 10 lb Pinch Gauge

Device Class : 1

Duns Number: 079605952

Premarket Exempt : Yes

Product Code : HRW

Prescription Use : No

Device Count : 1

B&L Engineering Hydraulic Hand Dynamometer - 00855144007039 Catalog Number :

Device Description : Hydraulic Hand Dynamometer

Device Class : 1

Duns Number: 079605952

Premarket Exempt : Yes

Product Code : HRW

Prescription Use : No

Device Count : 1

B&L Engineering Active EMG Surface Electrode - 00855144007046 Catalog Number :

Device Description : Active EMG Surface Electrode Narrow Spaced - No Ground

Device Class : 2

Duns Number: 079605952

Premarket Exempt : No

Product Code : IKN

Prescription Use : No

Device Count : 1

B&L Engineering Active Surface EMG Electrode - 00855144007053 Catalog Number :

Device Description : Active Surface EMG Electrode Wide Spaced - No Ground

Device Class : 2

Duns Number: 079605952

Premarket Exempt : No

Product Code : IKN

Prescription Use : No

Device Count : 1

B&L Engineering Active Surface EMG Electrode - 00855144007060 Catalog Number :

Device Description : Active Surface EMG Electrode Wide Spaced - Ground

Device Class : 2

Duns Number: 079605952

Premarket Exempt : No

Product Code : IKN

Prescription Use : No

Device Count : 1

B&L Engineering Active Surface EMG Electrode - 00855144007077 Catalog Number :

Device Description : Active Surface EMG Electrode with Snap

Device Class : 2

Duns Number: 079605952

Premarket Exempt : No

Product Code : IKN

Prescription Use : No

Device Count : 1

B&L Engineering EMG Electrode Interface Box - 00855144007084 Catalog Number :

Device Description : EMG Electrode Interface Box 6-channel

Device Class : 2

Duns Number: 079605952

Premarket Exempt : Yes

Product Code : IKN

Prescription Use : No

Device Count : 1

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