FDA Certificate for Cyma 1000

Device Listing Database

Proprietary Device Name:	CYMA 1000
Common/Generic Device Name:	ACOUSTIC MASSAGER
Classification Name:	MASSAGER, THERAPEUTIC, ELECTRIC
Device Class:	1
Product Code:	ISA
Regulation Number:	890.5660
Medical Specialty:	Physical Medicine
Owner/Operator:	WUNDER TOOL & DIE, INC.
Owner/Operator Number:	9071023
Registered Establishment Name:	WUNDER TOOL & DIE, INC.
Establishment Registration Number:	3003254412
Date of Listing:	02/11/05
Listing Status:	Active

[Revised as of April 1, 2006]
[CITE: 21CFR890.5660]
See Related Information on 890.5660 in CDRH databases
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 890 -- PHYSICAL MEDICINE DEVICES

F -- Subpart F--Physical Medicine Therapeutic Devices
Sec. 890.5660 Therapeutic massager.
(a) Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]