FDA UDI
In Commercial Distribution
🇺🇸 United States
PlayMakar
DI: 00856675008724
·
Model: PRO-1000-2
·
PLAYMAKAR INC.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PlayMakar
- Primary DI
- 00856675008724
- Version / Model
- PRO-1000-2
- Catalog Number
- PRO-1000-2
- Company Name
- PLAYMAKAR INC.
- Labeler DUNS
- 081212270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-16
- Public Version
- 1
- Public Version Date
- 2021-09-24
- Public Version Status
- New
- Public Device Record Key
- ded76817-5124-4edb-a7ae-c28b03025fb3
Device Description
PLAYMAKAR PRO STRENGTH AND RECOVERY SYSTEM (2 Pods)
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Neurology | 882.5890 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856675008724 | GS1 |
Customer Contacts
- Phone
- 8337529625
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161453 | 000 |