Current through Register Vol. 54, No. 44, November 2, 2024
The following words and terms when used in this chapter,
have the following meanings, unless the context clearly indicates
otherwise:
(i) An instrument, apparatus or contrivance,
including their components, parts and accessories, intended as follows:
(A) For use in the diagnosis, cure,
mitigation, treatment or prevention of disease of man or other
animals.
(B) To affect the
structure or a function of the body of man or other animals.
(ii) The term device shall include
the following:
(A) Artificial eyes.
(B) Artificial limbs.
(C) Bandages and dressings, including, but
not limited to, adhesive bandages, sterile gauze and cotton products, and
elastic bandages and braces.
(D)
Birth control devices, including, but not limited to, intrauterine devices,
prophylactics, and vaginal diaphragms.
(E) Blood pressure testing
apparatus.
(F) Body braces and
supports, including, but not limited to, crutches, walkers and orthopedic
braces and supports.
(G) Cardiac
pacemakers and accessories.
(H)
Colostomy and ileostomy appliances, bags and supplies.
(I) Corn pads or plasters.
(J) Dental materials which are transferred to
the patient, including, but not limited to, dentures, fillings, crowns, inlays,
bridges, and apparatus.
(K)
Dialysis machines and artificial kidneys.
(L) Electronic therapeutic or diagnostic
products.
(M) Eyeglasses and hard
contact lenses.
(N) Hearing
aids.
(O) Inhalation therapy
equipment and emergency breathing equipment, including but not limited to
atomizers, intermittent positive pressure breathing units, iron lungs,
vaporizers, and oxygen equipment.
(P) Lamps, ultra-violet or
infra-red.
(Q) Needles.
(R) Syringes.
(S) Physical therapy equipment for
professional or home use, including but not limited to diathermy machines,
electronic muscle stimulators, traction units, therapeutic vibrators, and
whirlpool units.
(T) Surgical
implants.
(U) Sutures.
(V) Thermometers.
(W) Urine test kits sold over-the-counter for
home use.
(X)
Wheelchairs.
The provisions of this §25.1 issued under section 2102 of
The Administrative Code of 1929 (71 P. S. §
532); and sections 6 and 35 of the Controlled
Substance, Drug, Device and Cosmetic Act (35 P. S. §§
780-106 and
780-135).
