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Enso

FDA UDI

Class II (US FDA UDI)

by Hinge Health, Inc.

Identity

Trade Name
Enso FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
Nerve stimulator for pain relief (manufactured in Malaysia) - 2 std., 1 back gel pad FDA UDI
Model / Reference
M3 FDA UDI
Description
Nerve stimulator for pain relief (manufactured in Malaysia) - 2 std., 1 back gel pad FDA UDI

Identifiers

Primary DI / UDI-DI
00850045950064 FDA UDI
510(k) Number
K233784 FDA UDI
FDA Product Code
NUH FDA UDI
NGX FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Enso by Hinge Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K233784 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hinge Health, Inc.

Sources (1)

  • FDA UDI 43318d2b-1796-4dcb-96e3-13708893c1f0 35 fields · synced May 30, 2026