Certification

Reference Standards

This article has been designed and manufactured in compliance with the safety requirements
laid down in Directive 93/42/EEC of 06/14/93 (class I) and subsequent amendments and additions (Directive 2007/47/EEC) concerning medical devices.

Intended use

Type: device for postural support.
Personnel in charge of adjustments: professional operators and doctors.
Supervision and responsibility: the treating physician.

Identification:
1. Name and address of the manufacturer.
2. Refer to the user manual.
3. Catalogue identification code.
4. Serial number.
5. Manufacturing Date.
6. Upholstery fabric.
7. Washing instructions.
8. EC mark.
9. Maximum patient weight

Declaration of Conformity

Firm: Ortopedia Antoniana
Address: Via P. Bembo, 144
35124 Padova PD
Product: Abbraccio®
The products described above are in accordance with:
Document No. 93/42/EEC
Council Directive 93/42/EEC of 14th June 1993 and subsequent amendments and additions, concerning medical devices.
Edition / Date of issue June 14th, 1993
Additional Information
The products are among those covered by the EU Directive no.
42/1993 in Class I in accordance with Rule 1 Section III of att. IX and are subject to
the procedure laid down by Article. 11 paragraph 5 of 93/42/EEC and subsequent
changes and additions (Directive 2007/47/EC).
Padova, 25 Maggio 2013