NALU MEDICAL, INC.

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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

Stimulator, Peripheral Nerve, Implanted (Pain Relief) (GZF) (10) Stimulator, Spinal-Cord, Implanted (Pain Relief) (GZB) (10)

Premarket Exempt

Clear

Nalu Medical, Inc. - 00812537030265 Catalog Number : 34004-US

Device Description : EIC Extension

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030333 Catalog Number : 34007-US

Device Description : Relief Belt (Black)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030463 Catalog Number : 53001

Device Description : SCS Programming App

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : No

Device Count : 1

Nalu Medical, Inc. - 00812537030470 Catalog Number : 53002-001

Device Description : SCS Remote App (compatible with Android)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : No

Device Count : 1

Nalu Medical, Inc. - 00812537030487 Catalog Number : 71001-US

Device Description : Nalu Neurostimulation Kit (Integrated, Single 8, 40 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030494 Catalog Number : 71002-US

Device Description : Nalu Neurostimulation Kit (Integrated, Dual 8, 40 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030500 Catalog Number : 71003-US

Device Description : Nalu IPG Kit (Ported, Single 8)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030517 Catalog Number : 71004-US

Device Description : Nalu IPG Kit (Ported, Dual 8)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030524 Catalog Number : 71005-US

Device Description : Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Nalu Medical, Inc. - 00812537030531 Catalog Number : 72001-US

Device Description : Lead Kit (8 contact, 40 cm)

Device Class : 2

Duns Number: 067140761

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

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