| 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]