FDA UDI
In Commercial Distribution
🇺🇸 United States
BEOKA
DI: 06950735811614
·
Model: ACM-A1/Black M (Luxury version)
·
SiChuan Qian Li Beoka Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BEOKA
- Primary DI
- 06950735811614
- Version / Model
- ACM-A1/Black M (Luxury version)
- Company Name
- SiChuan Qian Li Beoka Medical Technology Co., Ltd.
- Labeler DUNS
- 560529502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-08
- Public Version
- 1
- Public Version Date
- 2025-05-16
- Public Version Status
- New
- Public Device Record Key
- 64db27df-c9c5-4ba6-a903-38656c854c22
Device Description
The Air Compression Massager is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67203 | Wearable electric massager | An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06950735811614 | GS1 |
Customer Contacts
- Phone
- +86-13551356664
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241446 | 000 |