← Back to catalogue

Trulife

FDA UDI

Class I (US FDA UDI)

by Trulife, Inc.

Identity

Trade Name
Trulife FDA UDI
Generic Name
Mechanical-resistance external knee prosthesis FDA UDI
Device Name
SELECT STANCE FLEXION PNEUMATIC KNEE FDA UDI
Model / Reference
SSK615 FDA UDI
Description
SELECT STANCE FLEXION PNEUMATIC KNEE FDA UDI

Identifiers

Primary DI / UDI-DI
00645517547114 FDA UDI
FDA Product Code
ISY FDA UDI
GMDN Term
Mechanical-resistance external knee prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical-resistance external knee prosthesis

Trulife by Trulife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical-resistance external knee prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Trulife, Inc.

Sources (1)

  • FDA UDI bd64d128-9be5-4c30-895f-f68c0d379eb6 33 fields · synced Jun 4, 2026