FDA UDI In Commercial Distribution 🇺🇸 United States

e2™ Trapeze Handle & Strap

DI: 00689281020428 · Model: STP-HS · Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
e2™ Trapeze Handle & Strap
Primary DI
00689281020428
Version / Model
STP-HS
Catalog Number
02042
Company Name
Healthcraft Products Inc.
Labeler DUNS
252468293
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-08-30
Public Version
1
Public Version Date
2021-09-07
Public Version Status
New
Public Device Record Key
070f7f0a-235e-45ee-8f68-8d4006be241e

Device Description

The e2 Ceiling Mount Trapeze is an over-bed trapeze system that secures to the ceiling. The trapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can slide sideward / laterally on the ceiling mounted grab bar to store out of the way when not in use. The e2 Ceiling Mount Trapeze is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The grab bar is installed to a structural ceiling, and a metal hook is looped onto the grab bar. The trapeze handle is connected with an adjustable strap to the metal hook. The maximum user weight for this product is 300lbs / 136kgs. No more than 150lbs / 68kgs is to be exerted on the e2 trapeze (sitting support only). NOTE: Product is not intended to support full body weight. The e2 Ceiling Mount Trapeze is not to be used in any other way than described.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IKX Aid, Transfer

GMDN Terms

Code Name
35586 Hand rail

Identifiers

Type ID
Primary 00689281020428